Trial Outcomes & Findings for Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis (NCT NCT00622700)

NCT ID: NCT00622700

Last Updated: 2017-03-13

Results Overview

Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 618 participants
• Primary outcome timeframe: Up to a maximum of 108 weeks depending on time of enrollment
• Results posted on: 2017-03-13

Participant Flow

A total of 846 participants were screened, of which 618 randomized in core treatment period. Out of 618, 423 entered in extension treatment period. End date of core treatment period was 17 December 2012 (maximum treatment duration: 120 weeks). End date of extension treatment period was 05 February 2016 (maximum treatment duration: 283 weeks).

Participants were randomized in 1:1:1 ratio to teriflunomide 7 mg,14 mg or placebo in core treatment period. Those completing core period, given opportunity to enter long-term extension period (participants originally given placebo re-randomized [1:1]to teriflunomide 7 mg/14 mg; those originally given 7 mg,14 mg continued with the same fixed dose).

Participant milestones

Measure	Placebo Core treatment period: Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg Core treatment period: Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally.	Placebo/ Teriflunomide 7 mg Core treatment period: Placebo matched to teriflunomide tablet once daily orally. Extension treatment period: Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 7 mg/7 mg Core treatment period: Teriflunomide 7 mg tablet once daily orally. Extension treatment period: Teriflunomide 7 mg tablet once daily orally.	Placebo/Teriflunomide 14 mg Core treatment period: Placebo matched to teriflunomide tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period STARTED	197	205	216	0	0	0	0
Core Treatment Period Treated	197	203	214	0	0	0	0
Core Treatment Period COMPLETED	141	150	163	0	0	0	0
Core Treatment Period NOT COMPLETED	56	55	53	0	0	0	0
Extension Treatment Period STARTED	0	0	0	64	142	67	150
Extension Treatment Period COMPLETED	0	0	0	43	103	50	120
Extension Treatment Period NOT COMPLETED	0	0	0	21	39	17	30

Reasons for withdrawal

Measure	Placebo Core treatment period: Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg Core treatment period: Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally.	Placebo/ Teriflunomide 7 mg Core treatment period: Placebo matched to teriflunomide tablet once daily orally. Extension treatment period: Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 7 mg/7 mg Core treatment period: Teriflunomide 7 mg tablet once daily orally. Extension treatment period: Teriflunomide 7 mg tablet once daily orally.	Placebo/Teriflunomide 14 mg Core treatment period: Placebo matched to teriflunomide tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period Randomized but Not Treated	0	2	2	0	0	0	0
Core Treatment Period Adverse Event	18	25	18	0	0	0	0
Core Treatment Period Lack of Efficacy	19	6	12	0	0	0	0
Core Treatment Period Lost to Follow-up	1	1	1	0	0	0	0
Core Treatment Period Death	1	0	0	0	0	0	0
Core Treatment Period Progressive Disease	3	1	0	0	0	0	0
Core Treatment Period Withdrawal by Subject	12	18	15	0	0	0	0
Core Treatment Period Other than specified above	2	2	5	0	0	0	0
Extension Treatment Period Adverse Event	0	0	0	5	9	6	8
Extension Treatment Period Lack of Efficacy	0	0	0	2	8	1	9
Extension Treatment Period Protocol Violation	0	0	0	0	0	2	0
Extension Treatment Period Lost to Follow-up	0	0	0	0	1	0	0
Extension Treatment Period Progressive Disease	0	0	0	1	2	0	2
Extension Treatment Period Withdrawal by Subject	0	0	0	11	16	6	10
Extension Treatment Period Missing	0	0	0	2	3	1	0
Extension Treatment Period Other than specified above	0	0	0	0	0	1	1

Baseline Characteristics

Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis

Baseline characteristics by cohort

Measure	Placebo n=197 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=205 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=216 Participants Teriflunomide 14 mg tablet once daily orally.	Total n=618 Participants Total of all reporting groups
Age, Continuous	32.0 years STANDARD_DEVIATION 8.4 • n=5 Participants	31.6 years STANDARD_DEVIATION 9.0 • n=7 Participants	32.8 years STANDARD_DEVIATION 8.1 • n=5 Participants	32.7 years STANDARD_DEVIATION 8.9 • n=4 Participants
Sex: Female, Male Female	135 Participants n=5 Participants	130 Participants n=7 Participants	154 Participants n=5 Participants	419 Participants n=4 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	75 Participants n=7 Participants	62 Participants n=5 Participants	199 Participants n=4 Participants
Region Eastern Europe	94 participants n=5 Participants	96 participants n=7 Participants	101 participants n=5 Participants	291 participants n=4 Participants
Region Western Europe	76 participants n=5 Participants	74 participants n=7 Participants	74 participants n=5 Participants	224 participants n=4 Participants
Region Americas and Australia	27 participants n=5 Participants	35 participants n=7 Participants	41 participants n=5 Participants	103 participants n=4 Participants
Expanded Disability Status Scale (EDSS) Score	1.71 units on a scale STANDARD_DEVIATION 1.00 • n=5 Participants	1.50 units on a scale STANDARD_DEVIATION 1.02 • n=7 Participants	1.80 units on a scale STANDARD_DEVIATION 0.97 • n=5 Participants	1.67 units on a scale STANDARD_DEVIATION 1.00 • n=4 Participants

PRIMARY outcome

Timeframe: Up to a maximum of 108 weeks depending on time of enrollment

Population: Intent-to-treat (ITT) population included all randomized participants who had at least 1 day study medication exposure. Participants were analyzed in the treatment group to which they were randomized.

Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.

Outcome measures

Measure	Placebo n=197 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=203 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=214 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 24 weeks	14.3 percent probability Interval 9.2 to 19.4	8.7 percent probability Interval 4.6 to 12.8	9.0 percent probability Interval 5.0 to 13.0	—
Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 48 weeks	26.0 percent probability Interval 19.2 to 32.8	14.2 percent probability Interval 8.9 to 19.6	13.7 percent probability Interval 8.6 to 18.7	—
Core Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 108 weeks	35.9 percent probability Interval 27.8 to 43.9	27.6 percent probability Interval 19.9 to 35.4	24.0 percent probability Interval 17.0 to 31.0	—

SECONDARY outcome

Timeframe: Up to a maximum of 108 weeks depending on time of enrollment

Population: ITT population.

Conversion to DMS was demonstrated by dissemination of MRI lesions in time (as per McDonald criteria) or a relapse, whichever occurs first. MRI Imaging criteria were detection of Gadolinium (Gd) enhancement at least 3 months after onset of initial clinical event, if not at site corresponding to initial event; detection of new T2 lesion if it appears at any time compared with reference scan (done at time of screening) done at least 30 days after onset of the initial clinical event. Occurrence of relapse was defined as new neurological abnormality separated by at least 30 days from onset of preceding clinical event, present for at least 24 hours and occurring in absence of fever or known infection. New clinical abnormality (neurological sign) that is consistent with participant's symptoms with increase in at least one Functional System (FS) or EDSS score compared to last EDSS assessment. Percent probability of conversion at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.

Outcome measures

Measure	Placebo n=197 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=203 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=214 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS) Percent Probability of Conversion at 24 weeks	58.2 percent probability Interval 51.0 to 65.4	45.7 percent probability Interval 38.5 to 52.9	46.0 percent probability Interval 39.0 to 53.0	—
Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS) Percent Probability of Conversion at 48 weeks	72.4 percent probability Interval 65.7 to 79.1	57.3 percent probability Interval 49.8 to 64.7	57.8 percent probability Interval 50.6 to 64.9	—
Core Treatment Period: Time to Conversion to Definite Multiple Sclerosis (DMS) Percent Probability of Conversion at 108 weeks	87.0 percent probability Interval 81.2 to 92.7	73.3 percent probability Interval 66.0 to 80.7	71.5 percent probability Interval 64.5 to 78.4	—

SECONDARY outcome

Timeframe: Up to a maximum of 108 weeks depending on time of enrollment

Population: ITT population.

ARR is the total number of confirmed relapses that occurred during the treatment period divided by the total number of patient-years treated. Each episode of relapse (appearance, or worsening of a clinical symptom that was stable for at least 30 days, that persisted for a minimum of 24 hours in the absence of fever) was to be confirmed by an increase in EDSS score or Functional System scores. ARR was assessed using Poisson regression model with robust error variance. To account for the different treatment durations among participants, a Poisson regression model with robust error variance was used (total number of confirmed relapses onset between randomization date and last dose date as the response variable, treatment, region and baseline monofocal/multifocal status as covariates, and log-transformed treatment duration as an offset variable).

Outcome measures

Measure	Placebo n=197 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=203 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=214 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Annualized Relapse Rate (ARR)	0.284 relapses per patient year Interval 0.214 to 0.378	0.190 relapses per patient year Interval 0.139 to 0.26	0.194 relapses per patient year Interval 0.143 to 0.263	—

SECONDARY outcome

Timeframe: Baseline, Week 108

Population: ITT population, but including only participants who had post-baseline data.

The total lesion volume (burden of disease) is the total volumes of hyperintense on T2 plus hypointense on T1 as measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data with factors for treatment, baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline burden of disease, and baseline-by-visit interaction.

Outcome measures

Measure	Placebo n=68 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=75 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=99 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Brain Magnetic Resonance Imaging (MRI) Assessment: Change From Baseline in Total Lesion Volume at Week 108	0.053 milliliter Standard Error 0.033	0.041 milliliter Standard Error 0.032	-0.038 milliliter Standard Error 0.029	—

SECONDARY outcome

Timeframe: Up to a maximum of 108 weeks depending on time of enrollment

Population: ITT population, but including only participants who had post-baseline data.

Number of Gd-enhancing T1-lesions per scan is the total number of Gd-enhancing T1-lesions that occurred during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).

Outcome measures

Measure	Placebo n=109 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=84 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=74 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Brain MRI Assessment: Number of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan (Poisson Regression Estimates)	0.953 lesions per scan Interval 0.708 to 1.284	0.749 lesions per scan Interval 0.433 to 1.294	0.395 lesions per scan Interval 0.262 to 0.598	—

SECONDARY outcome

Timeframe: Up to a maximum of 108 weeks depending on time of enrollment

Population: ITT population, but including only participants who had post-baseline data.

Total volume of Gd-enhancing T1-lesions per scan is the sum of the volumes of Gd-enhancing T1-lesions observed during the treatment period divided by the total number of scans performed during the treatment period. To account for the different numbers of scans performed among the participants, a Poisson regression model with robust error variance was used (total number of Gd-enhancing T1-lesions as response variable, treatment, baseline monofocal/multifocal status, region and baseline number of Gd-enhancing T1-lesions as covariates, and log-transformed number of scans as an offset variable).

Outcome measures

Measure	Placebo n=109 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=84 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=74 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Brain MRI Assessment: Volume of Gadolinium Enhancing (Gd-enhancing) T1-lesions Per MRI Scan	0.079 milliliters per scan	0.058 milliliters per scan	0.034 milliliters per scan	—

SECONDARY outcome

Timeframe: Baseline, Week 108

Population: ITT population, but including only participants who had post-baseline data.

Volume of hypointense post-gadolinium T1 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction

Outcome measures

Measure	Placebo n=68 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=75 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=99 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of Hypointense Post-Gadolinium T1 Lesion Component	0.028 milliliter Standard Error 0.018	0.025 milliliter Standard Error 0.018	-0.033 milliliter Standard Error 0.016	—

SECONDARY outcome

Timeframe: Baseline, Week 108

Population: ITT population, but including only participants who had post-baseline data.

Volume of T2 lesion component was measured by MRI scan. Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, cubic root transformed baseline value, and baseline-by-visit interaction.

Outcome measures

Measure	Placebo n=68 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=75 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=99 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Brain MRI Assessment: Change From Baseline in Volume of T2 Lesion Component	0.052 milliliter Standard Error 0.033	0.036 milliliter Standard Error 0.032	-0.035 milliliter Standard Error 0.029	—

SECONDARY outcome

Timeframe: Baseline, Week 108

Population: ITT population, but including only participants who had post-baseline data.

Atrophy was measured by MRI scan.

Outcome measures

Measure	Placebo n=68 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=75 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=99 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Brain MRI Assessment: Percent Change From Baseline in Atrophy	-0.386 percent change Standard Deviation 1.326	-0.197 percent change Standard Deviation 1.218	-0.366 percent change Standard Deviation 1.151	—

SECONDARY outcome

Timeframe: Up to a maximum of 108 weeks depending on time of enrollment

Population: ITT population.

The 12-week sustained disability progression was defined as increase from baseline of at least 1-point in EDSS score (at least 0.5-point for participants with baseline EDSS score of greater than [>] 5.5) that persisted for at least 12 weeks. Percent probability of participants free of 12-week sustained disability progression at 24, 48, and 108 weeks was estimated using Kaplan-Meier method.

Outcome measures

Measure	Placebo n=197 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=203 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=214 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Time to 12-Week Sustained Disability Progression Percent Probability at 24 weeks	96.0 percent probability Interval 93.0 to 98.9	94.3 percent probability Interval 90.9 to 97.8	97.9 percent probability Interval 95.9 to 99.9	—
Core Treatment Period: Time to 12-Week Sustained Disability Progression Percent Probability at 48 weeks	91.7 percent probability Interval 87.3 to 96.1	90.1 percent probability Interval 85.4 to 94.7	93.9 percent probability Interval 90.2 to 97.6	—
Core Treatment Period: Time to 12-Week Sustained Disability Progression Percent Probability at 108 weeks	85.5 percent probability Interval 79.2 to 91.8	86.5 percent probability Interval 80.8 to 92.1	89.2 percent probability Interval 84.1 to 94.3	—

SECONDARY outcome

Timeframe: Baseline, Week 108

Population: ITT population, but including only participants who had post-baseline data.

EDSS is an ordinal scale in half-point increments that qualifies disability in participants with MS. It consists of 8 ordinal rating scales assessing seven functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score ranges from 0 (normal neurological examination) to 10 (death due to MS). Least-square means were estimated using a Mixed-effect model with repeated measures (MMRM) on cubic root transformed volume data adjusted for baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction

Outcome measures

Measure	Placebo n=80 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=82 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=102 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Change From Baseline in EDSS at Week 108	0.069 units on a scale Standard Error 0.087	-0.191 units on a scale Standard Error 0.086	-0.166 units on a scale Standard Error 0.080	—

SECONDARY outcome

Timeframe: Baseline, Week 108

Population: ITT population, but including only participants who had post-baseline data.

FIS is a participant-reported scale that qualifies the impact of fatigue on daily life in participants with MS. It consists of 40 statements that measure fatigue in three areas; physical, cognitive, and social. FIS total score ranges from 0 (no problem) to 160 (extreme problem). Least-square means were estimated using a Mixed-effect model with repeated measures [MMRM] on FIS total score data adjusted for or baseline monofocal/multifocal status, region, visit, treatment-by-visit interaction, baseline value and baseline-by-visit interaction.

Outcome measures

Measure	Placebo n=84 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=95 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=106 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Change From Baseline in Fatigue Impact Scale (FIS) Total Score at Week 108	-2.537 units on a scale Standard Error 2.794	-2.524 units on a scale Standard Error 2.710	-1.827 units on a scale Standard Error 2.551	—

SECONDARY outcome

Timeframe: From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first

Population: Safety population:all randomized participants exposed to study medication; analyzed according to drug actually received. In Placebo arm, 4 received teriflunomide 7mg \& 2 received teriflunomide 14mg, hence they were included in respective teriflunomide arm. Participants who were randomized but not treated were excluded (2 in each teriflunomide arm).

AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study.

Outcome measures

Measure	Placebo n=191 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=207 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=216 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Overview of Adverse Events (AEs) Any AE	155 participants	161 participants	183 participants	—
Core Treatment Period: Overview of Adverse Events (AEs) Any serious AE	18 participants	18 participants	24 participants	—
Core Treatment Period: Overview of Adverse Events (AEs) Any AE leading to death	1 participants	0 participants	0 participants	—
Core Treatment Period: Overview of Adverse Events (AEs) Any AE leading to treatment discontinuation	19 participants	25 participants	18 participants	—

SECONDARY outcome

Timeframe: From randomization in the core period up to 390 Weeks (Extension treatment period [maximum exposure: 283 Weeks])

Population: ITT Population: all randomized participants in the extension who had at least 1 day IMP exposure. Participants were analyzed according to the treatment group allocated by the randomization in the core study followed by the re-randomized treatment group during the extension period.

Conversion to CDMS was defined by the occurrence of a relapse, which was defined as a new neurological abnormality separated by at least 30 days from onset of a preceding clinical event, presented for at least 24 hours and occurred in the absence of fever or known infection. Percent probability of conversion was estimated using Kaplan-Meier method.

Outcome measures

Measure	Placebo n=64 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=142 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=67 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg n=150 Participants Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 264 Weeks	29.5 Percent probability Interval 16.1 to 42.9	43.0 Percent probability Interval 32.9 to 53.2	39.3 Percent probability Interval 26.3 to 52.3	26.3 Percent probability Interval 18.7 to 34.0
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 336 Weeks	29.5 Percent probability Interval 16.1 to 42.9	48.7 Percent probability Interval 34.7 to 62.7	49.4 Percent probability Interval 28.3 to 70.5	26.3 Percent probability Interval 18.7 to 34.0
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 24 Weeks	4.7 Percent probability Interval 0.0 to 9.9	3.5 Percent probability Interval 0.5 to 6.6	13.5 Percent probability Interval 5.3 to 21.6	4.7 Percent probability Interval 1.3 to 8.0
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 48 Weeks	12.5 Percent probability Interval 4.4 to 20.6	9.9 Percent probability Interval 5.0 to 14.8	21.2 Percent probability Interval 11.3 to 31.0	8.7 Percent probability Interval 4.2 to 13.3
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 72 Weeks	15.7 Percent probability Interval 6.8 to 24.6	17.1 Percent probability Interval 10.9 to 23.4	24.3 Percent probability Interval 13.9 to 34.6	14.8 Percent probability Interval 9.1 to 20.6
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 96 Weeks	18.9 Percent probability Interval 9.3 to 28.6	23.9 Percent probability Interval 16.7 to 31.0	27.4 Percent probability Interval 16.6 to 38.2	16.2 Percent probability Interval 10.3 to 22.1
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 120 Weeks	22.3 Percent probability Interval 12.0 to 32.7	27.7 Percent probability Interval 20.2 to 35.2	32.2 Percent probability Interval 20.8 to 43.6	18.3 Percent probability Interval 12.1 to 24.6
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 144 Weeks	22.3 Percent probability Interval 12.0 to 32.7	29.4 Percent probability Interval 21.7 to 37.1	33.9 Percent probability Interval 22.3 to 45.4	22.0 Percent probability Interval 15.3 to 28.8
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 168 Weeks	22.3 Percent probability Interval 12.0 to 32.7	32.2 Percent probability Interval 24.2 to 40.3	33.9 Percent probability Interval 22.3 to 45.4	22.8 Percent probability Interval 16.0 to 29.7
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 192 Weeks	22.3 Percent probability Interval 12.0 to 32.7	37.5 Percent probability Interval 28.6 to 46.4	35.9 Percent probability Interval 24.0 to 47.8	24.8 Percent probability Interval 17.6 to 32.0
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 216 Weeks	25.6 Percent probability Interval 13.9 to 37.3	38.9 Percent probability Interval 29.8 to 48.1	39.3 Percent probability Interval 26.3 to 52.3	24.8 Percent probability Interval 17.6 to 32.0
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 240 Weeks	29.5 Percent probability Interval 16.1 to 42.9	40.8 Percent probability Interval 31.3 to 50.4	39.3 Percent probability Interval 26.3 to 52.3	26.3 Percent probability Interval 18.7 to 34.0
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 288 Weeks	29.5 Percent probability Interval 16.1 to 42.9	43.0 Percent probability Interval 32.9 to 53.2	39.3 Percent probability Interval 26.3 to 52.3	26.3 Percent probability Interval 18.7 to 34.0
Extension Treatment Period: Time to Conversion to Clinically Definite Multiple Sclerosis (CDMS) Percent Probability of Conversion at 312 Weeks	29.5 Percent probability Interval 16.1 to 42.9	43.0 Percent probability Interval 32.9 to 53.2	49.4 Percent probability Interval 28.3 to 70.5	26.3 Percent probability Interval 18.7 to 34.0

SECONDARY outcome

Timeframe: From re-randomization up to 283 Weeks

Population: Analysis was performed on Safety population. In Placebo/teriflunomide 7mg arm, 2 received 7mg in the core period; In Placebo/teriflunomide 14mg, 1 received 7mg in the core period, hence, they were included in the 7mg/7mg arm in extension period as treatment received in the core period for consistency.

AEs are any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the participant during the study. Safety population included all randomized population who actually received at least 1 dose of the IMP in extension and analyzed according to the treatment actually received in core study followed by treatment actually received in the extension treatment period.

Outcome measures

Measure	Placebo n=62 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=145 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=66 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg n=150 Participants Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Extension Treatment Period: Overview of Adverse Events (AEs) Any AE Leading to Death	0 participants	0 participants	0 participants	0 participants
Extension Treatment Period: Overview of Adverse Events (AEs) Any AE leading to Permanent Discontinuation	5 participants	8 participants	5 participants	7 participants
Extension Treatment Period: Overview of Adverse Events (AEs) Any AE	47 participants	110 participants	57 participants	120 participants
Extension Treatment Period: Overview of Adverse Events (AEs) Any Serious AE	8 participants	17 participants	8 participants	24 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From first study drug intake up to 112 days after last intake in the placebo-controlled period or up to first intake in the extension treatment period, whichever occurred first

Population: Safety population as described in Outcome Measure 13. Here 'n' signifies the number of participants for the treatment group who had that parameter assessed at post-baseline.

PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.

Hepatic parameters thresholds were defined as follows:

• Alanine Aminotransferase (ALT) >3, 5, 10 or 20 upper limit of normal(ULN);
• Aspartate aminotransferase (AST) >3, 5, 10 or 20 ULN;
• Alkaline Phosphatase >1.5 ULN;
• Total Bilirubin (TB) >1.5, 2, or 3 ULN;
• ALT >3 ULN and TB >2 ULN.

Outcome measures

Measure	Placebo n=191 Participants Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=207 Participants Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=216 Participants Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) ALT >3 ULN (n=190, 207, 216)	18 participants	25 participants	26 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) ALT >5 ULN (n=190, 207, 216)	12 participants	10 participants	11 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) ALT >10 ULN (n=190, 207, 216)	5 participants	1 participants	3 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) ALT >20 ULN (n=190, 207, 216)	0 participants	0 participants	1 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) AST >3 ULN (n=190, 207, 216)	9 participants	12 participants	10 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) AST >5 ULN (n=190, 207, 216)	1 participants	4 participants	6 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) AST >10 ULN (n=190, 207, 216)	1 participants	0 participants	1 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) AST >20 ULN (n=190, 207, 216)	0 participants	0 participants	1 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) Alkaline Phosphatase >1.5 ULN (n=190, 207, 216)	0 participants	0 participants	1 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) TB >1.5 ULN (n=190, 207, 216)	14 participants	9 participants	8 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) TB >2 ULN (n=190, 207, 216)	8 participants	0 participants	3 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) TB >3 ULN (n=190, 207, 216)	0 participants	0 participants	1 participants	—
Core Treatment Period: Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities (PCSA) ALT >3 ULN and TB >2 ULN (n=190, 207, 216)	2 participants	0 participants	2 participants	—

Adverse Events

Placebo

Serious events: 18 serious events

Other events: 117 other events

Deaths: 0 deaths

Teriflunomide 7 mg

Serious events: 18 serious events

Other events: 129 other events

Deaths: 0 deaths

Teriflunomide 14 mg

Serious events: 24 serious events

Other events: 135 other events

Deaths: 0 deaths

Placebo/Teriflunomide 7 mg

Serious events: 8 serious events

Other events: 33 other events

Deaths: 0 deaths

Teriflunomide 7 mg/7 mg

Serious events: 17 serious events

Other events: 66 other events

Deaths: 0 deaths

Placebo/Teriflunomide 14 mg

Serious events: 8 serious events

Other events: 38 other events

Deaths: 0 deaths

Teriflunomide 14 mg/14 mg

Serious events: 24 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=191 participants at risk Core treatment period: Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=207 participants at risk Core treatment period: Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=216 participants at risk Core treatment period: Teriflunomide 14 mg tablet once daily orally.	Placebo/Teriflunomide 7 mg n=62 participants at risk Core treatment period: Placebo matched to teriflunomide tablet once daily orally. Extension treatment period: Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 7 mg/7 mg n=145 participants at risk Core treatment period: Teriflunomide 7 mg tablet once daily orally. Extension treatment period: Teriflunomide 7 mg tablet once daily orally.	Placebo/Teriflunomide 14 mg n=66 participants at risk Core treatment period: Placebo matched to teriflunomide tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg n=150 participants at risk Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Infections and infestations Abdominal wall abscess	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Acute sinusitis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Dengue fever	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Gastroenteritis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Pneumonia	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Abdominal abscess	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Appendicitis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.93% 2/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Appendicitis perforated	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Bronchitis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Clostridium difficile colitis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Cystitis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Genital infection	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Infectious mononucleosis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Pharyngitis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Pilonidal cyst	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Pulmonary tuberculosis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Pyelonephritis acute	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Rectal abscess	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Sinusitis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Investigations Aspartate aminotransferase increased	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	1.0% 2/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal meningioma benign	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Blood and lymphatic system disorders Neutropenia	1.0% 2/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.4% 2/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Endocrine disorders Goitre	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Psychiatric disorders Adjustment disorder	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Psychiatric disorders Completed suicide	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Psychiatric disorders Depression	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Psychiatric disorders Psychiatric decompensation	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Psychiatric disorders Suicide attempt	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Nervous system disorders Radicular syndrome	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Nervous system disorders Axonal neuropathy	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Nervous system disorders Loss of consciousness	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Nervous system disorders Speech disorder	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Eye disorders Conjunctivitis allergic	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Ear and labyrinth disorders Vertigo	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Cardiac disorders Supraventricular tachycardia	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Cardiac disorders Tachycardia	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Vascular disorders Circulatory collapse	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Vascular disorders Hypertension	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Vascular disorders Orthostatic hypotension	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Vascular disorders Deep vein thrombosis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Chronic gastritis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Duodenitis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Abdominal pain	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Dental cyst	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Gastroduodenal ulcer	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Inguinal hernia	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Pancreatitis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Peptic ulcer	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Radicular cyst	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Hepatobiliary disorders Cholelithiasis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Hepatobiliary disorders Cholecystitis	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Hepatobiliary disorders Cholecystitis acute	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Skin and subcutaneous tissue disorders Diffuse alopecia	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Skin and subcutaneous tissue disorders Erythema nodosum	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Pregnancy, puerperium and perinatal conditions Abortion threatened	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.93% 2/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Reproductive system and breast disorders Cervical cyst	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Reproductive system and breast disorders Fallopian tube cyst	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Reproductive system and breast disorders Menorrhagia	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Reproductive system and breast disorders Testicular torsion	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
General disorders Hernia	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Investigations Amylase increased	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.3% 2/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Investigations Blood creatine phosphokinase increased	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.3% 2/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Investigations Lipase increased	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.93% 2/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Investigations Transaminases increased	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Investigations Alanine aminotransferase increased	1.6% 3/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.4% 5/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.9% 4/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Investigations Weight decreased	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.48% 1/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Injury, poisoning and procedural complications Overdose	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.4% 2/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.46% 1/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.

Other adverse events

Measure	Placebo n=191 participants at risk Core treatment period: Placebo matched to teriflunomide tablet once daily orally.	Teriflunomide 7 mg n=207 participants at risk Core treatment period: Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 14 mg n=216 participants at risk Core treatment period: Teriflunomide 14 mg tablet once daily orally.	Placebo/Teriflunomide 7 mg n=62 participants at risk Core treatment period: Placebo matched to teriflunomide tablet once daily orally. Extension treatment period: Teriflunomide 7 mg tablet once daily orally.	Teriflunomide 7 mg/7 mg n=145 participants at risk Core treatment period: Teriflunomide 7 mg tablet once daily orally. Extension treatment period: Teriflunomide 7 mg tablet once daily orally.	Placebo/Teriflunomide 14 mg n=66 participants at risk Core treatment period: Placebo matched to teriflunomide tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.	Teriflunomide 14 mg/14 mg n=150 participants at risk Core treatment period: Teriflunomide 14 mg tablet once daily orally. Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Infections and infestations Nasopharyngitis	15.2% 29/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	11.6% 24/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	16.2% 35/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	14.5% 9/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	9.7% 14/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	13.6% 9/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	10.0% 15/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Bronchitis	2.6% 5/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.3% 9/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.7% 8/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.5% 4/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.8% 7/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.0% 2/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	5.3% 8/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Sinusitis	4.7% 9/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.4% 7/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.8% 6/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	9.7% 6/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.8% 4/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.1% 4/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.0% 6/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Influenza	4.7% 9/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.9% 8/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	7.4% 16/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.8% 3/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.4% 5/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	7.6% 5/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.7% 4/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Upper respiratory tract infection	7.3% 14/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	11.1% 23/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	9.3% 20/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.2% 2/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.4% 5/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.0% 2/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.7% 4/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Infections and infestations Urinary tract infection	5.2% 10/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.8% 10/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	9.3% 20/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.8% 3/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.4% 5/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	7.6% 5/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.7% 4/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Psychiatric disorders Depression	5.8% 11/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.9% 8/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.7% 8/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.2% 2/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.8% 4/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.5% 3/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.67% 1/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Nervous system disorders Headache	13.1% 25/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	15.0% 31/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	13.9% 30/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.5% 4/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	5.5% 8/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	12.1% 8/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.0% 6/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Nervous system disorders Dizziness	3.7% 7/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.4% 7/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	5.1% 11/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.8% 4/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.0% 2/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.7% 4/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Nervous system disorders Paraesthesia	4.7% 9/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	5.3% 11/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	10.2% 22/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.8% 3/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.5% 3/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.7% 4/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Vascular disorders Hypertension	1.0% 2/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.4% 5/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	5.6% 12/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.8% 3/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.8% 4/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.3% 5/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.2% 8/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	5.3% 11/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.93% 2/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.0% 2/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Diarrhoea	6.3% 12/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	10.6% 22/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.9% 15/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.5% 4/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.2% 9/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.1% 4/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	9.3% 14/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Gastrointestinal disorders Nausea	4.7% 9/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	5.3% 11/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.2% 9/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.2% 2/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.8% 7/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.0% 9/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Skin and subcutaneous tissue disorders Alopecia	7.9% 15/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	5.8% 12/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	11.6% 25/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.2% 2/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.1% 3/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	10.6% 7/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.3% 5/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Musculoskeletal and connective tissue disorders Back pain	3.7% 7/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.8% 14/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.7% 8/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.5% 4/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.4% 5/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.1% 4/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.7% 10/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Musculoskeletal and connective tissue disorders Arthralgia	3.1% 6/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.3% 13/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.2% 7/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.6% 1/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.8% 4/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.0% 2/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.7% 4/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
General disorders Fatigue	7.3% 14/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.8% 10/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.2% 9/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.2% 2/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.1% 3/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.1% 4/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.0% 3/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Investigations Alanine aminotransferase increased	14.7% 28/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	15.5% 32/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	16.2% 35/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.00% 0/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	3.4% 5/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	9.1% 6/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.0% 3/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.
Investigations Blood creatine phosphokinase increased	0.52% 1/191 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	4.3% 9/207 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	2.3% 5/216 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	6.5% 4/62 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	0.69% 1/145 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.5% 1/66 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.	1.3% 2/150 • All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (up to 390 weeks [maximum exposure in core treatment period: 120 weeks and maximum exposure in extension treatment period: 283 weeks]) regardless of seriousness or relationship to investigational product. Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'on treatment period' (time from first dose of study drug up to 112 days after last intake in core treatment period \[or up to 1st intake in extension period, whichever occurred first\] or 28 days after last intake in extension treatment period). Analysis was performed on safety population as described in Outcome Measure 15.

Additional Information

Trial Transparency Team

Sanofi

Email: Contact-us@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER