Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease (NCT NCT03186989)

Last Updated: 2025-04-08

Results Overview

An adverse event (AE) was defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of medicinal (investigational) product, whether or not the AE was considered related to the medicinal (investigational) product. A TEAE was defined as any AE that starts or worsens on or after the date of first dose of study treatment. TEAEs were categorised as mild, moderate, and severe to aid in severity assessment.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

46 participants

Primary outcome timeframe

From first dose of study drug up to Week 37 in Part 1

Results posted on

2025-04-08

Participant Flow

The study was conducted at 12 investigative sites in the Germany, United Kingdom, the Netherlands, Sweden, Canada, and Finland from 23 August 2017 to 12 May 2022.

A total of 102 participants were screened and 46 participants with mild Alzheimer's disease were enrolled and randomized to receive ISIS 814907 or placebo in Part 1 (multiple ascending dose \[MAD\]). This study consists of two parts i.e., Part 1: MAD and Part 2: long-term extension (LTE). Out of 46 participants enrolled in Part 1, 33 participants who met the pre-specified eligibility criteria transitioned into Part 2.

Participant milestones

Participant milestones
Measure	Part 1: Cohort A: ISIS 814907 10 mg Participants received 10 milligrams (mg) ISIS 814907 diluted in 20 millilitres (mL) artificial cerebrospinal fluid (CSF), intrathecally, every four weeks (Q4W) on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, every 12 weeks (Q12W) on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Late Start Cohort A + Cohort B + Cohort C + ISIS 814907 60 mg Participants from MAD Cohorts A, B, C that were placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Late Start Cohort D + ISIS 814907 115 mg Participants from MAD Cohort D that were placebo-treated, received 115 mg ISIS 814907 diluted up in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort A + ISIS 814907 60 mg Participants from MAD Cohort A that were ISIS 814907 10 mg -treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort B + ISIS 814907 60 mg Participants from MAD Cohort B that were ISIS 814907 30 mg-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort C + ISIS 814907 60 mg Participants from MAD Cohort C that were ISIS 814907 60 mg-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort D + ISIS 814907 115 mg Participants from MAD Cohort D that were ISIS 814907 115 mg-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
Part 1: MAD (Day 1 up to Week 36) STARTED	6	6	9	13	12	0	0	0	0	0	0
Part 1: MAD (Day 1 up to Week 36) COMPLETED	6	6	8	12	11	0	0	0	0	0	0
Part 1: MAD (Day 1 up to Week 36) NOT COMPLETED	0	0	1	1	1	0	0	0	0	0	0
Part 2: LTE (Week 37 to Week 101) STARTED	0	0	0	0	0	4	4	3	5	7	10
Part 2: LTE (Week 37 to Week 101) COMPLETED	0	0	0	0	0	2	2	3	4	7	10
Part 2: LTE (Week 37 to Week 101) NOT COMPLETED	0	0	0	0	0	2	2	0	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Cohort C: ISIS 814907 60 mg Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, every 12 weeks (Q12W) on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Late Start Cohort A + Cohort B + Cohort C + ISIS 814907 60 mg Participants from MAD Cohorts A, B, C that were placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Late Start Cohort D + ISIS 814907 115 mg Participants from MAD Cohort D that were placebo-treated, received 115 mg ISIS 814907 diluted up in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort B + ISIS 814907 60 mg Participants from MAD Cohort B that were ISIS 814907 30 mg-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
Part 1: MAD (Day 1 up to Week 36) Voluntary Withdrawal	1	1	1	0	0	0
Part 2: LTE (Week 37 to Week 101) Voluntary Withdrawal	0	0	0	1	0	0
Part 2: LTE (Week 37 to Week 101) Investigator Judgement	0	0	0	0	1	0
Part 2: LTE (Week 37 to Week 101) Adverse Event or Serious Adverse Event (SAE)	0	0	0	1	1	1

Baseline Characteristics

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS-MAPTRx in Patients With Mild Alzheimer's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Cohort A: ISIS 814907 10 mg n=6 Participants Participants received 10 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg n=6 Participants Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg n=9 Participants Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg n=13 Participants Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo n=12 Participants Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Total n=46 Participants Total of all reporting groups
Age, Continuous	63.5 years STANDARD_DEVIATION 5.2 • n=93 Participants	65.0 years STANDARD_DEVIATION 6.1 • n=4 Participants	65.6 years STANDARD_DEVIATION 6.8 • n=27 Participants	66.9 years STANDARD_DEVIATION 6.3 • n=483 Participants	66.3 years STANDARD_DEVIATION 4.6 • n=36 Participants	65.8 years STANDARD_DEVIATION 5.7 • n=10 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants	6 Participants n=483 Participants	6 Participants n=36 Participants	23 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	7 Participants n=483 Participants	6 Participants n=36 Participants	23 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants	13 Participants n=483 Participants	11 Participants n=36 Participants	45 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants	13 Participants n=483 Participants	12 Participants n=36 Participants	46 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 37 in Part 1

Population: Safety population included all participants who were randomised and received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A: ISIS 814907 10 mg n=6 Participants Participants received 10 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg n=6 Participants Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg n=9 Participants Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg n=13 Participants Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo n=12 Participants Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Early Start Cohort D + ISIS 814907 115 mg Participants from MAD Cohort D that were ISIS 814907 115 mg-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort C + ISIS 814907 60 mg Participants from MAD Cohort C that were ISIS 814907 60 mg-treated or placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort D + ISIS 814907 115 mg Participants from MAD Cohort D that were ISIS 814907 115 mg-treated or placebo-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
Part 1: Number of Participants With Adverse Events That Are Related to Treatment With ISIS 814907 Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—
Part 1: Number of Participants With Adverse Events That Are Related to Treatment With ISIS 814907 Mild	3 Participants	0 Participants	5 Participants	4 Participants	0 Participants	—	—	—
Part 1: Number of Participants With Adverse Events That Are Related to Treatment With ISIS 814907 Moderate	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: From first dose of study drug up to Week 64 in Part 2

Population: Safety population included all participants who were randomised and received at least 1 dose of study drug.

An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of medicinal (investigational) product, whether or not the AE was considered related to the medicinal (investigational) product. A TEAE was defined as any AE that starts or worsens on or after the date of first dose of study treatment. TEAEs were categorised as mild, moderate, and severe to aid in severity assessment.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A: ISIS 814907 10 mg n=4 Participants Participants received 10 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg n=4 Participants Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg n=3 Participants Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg n=5 Participants Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo n=7 Participants Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Early Start Cohort D + ISIS 814907 115 mg n=10 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort C + ISIS 814907 60 mg Participants from MAD Cohort C that were ISIS 814907 60 mg-treated or placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort D + ISIS 814907 115 mg Participants from MAD Cohort D that were ISIS 814907 115 mg-treated or placebo-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
Part 2: Number of Participants With Adverse Events That Are Related to Treatment With ISIS 814907 Mild	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants	—	—
Part 2: Number of Participants With Adverse Events That Are Related to Treatment With ISIS 814907 Moderate	0 Participants	2 Participants	1 Participants	1 Participants	1 Participants	3 Participants	—	—
Part 2: Number of Participants With Adverse Events That Are Related to Treatment With ISIS 814907 Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: Pre dose on Day 85 in Part 1 and Day 337 in Part 2

Population: PK population consisted of all participants who were randomized, received at least 1 dose of ISIS 814907, and had sufficient sampling (at least 1 evaluable post-Baseline PK sample) to permit PK evaluation. Overall number of participants analyzed is number of participants who received active treatment (ISIS 814907) in Part 1 or received active treatment in Part 2. As pre-specified in SAP, in case of very few participants in any active treatment groups, the analysis groups may have been pooled.

Outcome measures

Outcome measures
Measure	Part 1: Cohort A: ISIS 814907 10 mg n=6 Participants Participants received 10 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg n=6 Participants Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg n=9 Participants Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg n=12 Participants Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo n=2 Participants Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Early Start Cohort D + ISIS 814907 115 mg n=5 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort C + ISIS 814907 60 mg n=9 Participants Participants from MAD Cohort C that were ISIS 814907 60 mg-treated or placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort D + ISIS 814907 115 mg n=11 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated or placebo-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
CSF Trough Concentration of ISIS 814907	5.56 nanogram per millilitre (ng/mL) Standard Deviation 2.12	9.77 nanogram per millilitre (ng/mL) Standard Deviation 3.46	9.79 nanogram per millilitre (ng/mL) Standard Deviation 3.42	3.26 nanogram per millilitre (ng/mL) Standard Deviation 1.24	5.96 nanogram per millilitre (ng/mL) Standard Deviation NA The values were non-quantifiable \[NQ\] (50% of values were imputed i.e., NQ assigned zero concentration for one participant) which affected the calculation. Since only one participant had evaluable data SD was not estimable.	8.22 nanogram per millilitre (ng/mL) Standard Deviation 2.03	6.61 nanogram per millilitre (ng/mL) Standard Deviation 2.89	7.82 nanogram per millilitre (ng/mL) Standard Deviation 2.52

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, and 5 hours post-intrathecal (IT) bolus injection on Day 85 in Part 1 and on Day 337 in Part 2

Outcome measures

Outcome measures
Measure	Part 1: Cohort A: ISIS 814907 10 mg n=6 Participants Participants received 10 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg n=6 Participants Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg n=9 Participants Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg n=13 Participants Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo n=2 Participants Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Early Start Cohort D + ISIS 814907 115 mg n=5 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort C + ISIS 814907 60 mg n=9 Participants Participants from MAD Cohort C that were ISIS 814907 60 mg-treated or placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort D + ISIS 814907 115 mg n=12 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated or placebo-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
Maximum Observed Drug Concentration (Cmax) of ISIS 814907 in Plasma	65.4 ng/mL Geometric Coefficient of Variation 203	285 ng/mL Geometric Coefficient of Variation 50.5	542 ng/mL Geometric Coefficient of Variation 148	830 ng/mL Geometric Coefficient of Variation 879	840 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable due to insufficient number of participants with events.	323 ng/mL Geometric Coefficient of Variation 56.6	524 ng/mL Geometric Coefficient of Variation 90.2	1011 ng/mL Geometric Coefficient of Variation 130

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, and 5 hours post-IT bolus injection on Day 85 in Part 1 and on Day 337 in Part 2

Outcome measures

Outcome measures
Measure	Part 1: Cohort A: ISIS 814907 10 mg n=6 Participants Participants received 10 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg n=6 Participants Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg n=9 Participants Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg n=13 Participants Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo n=2 Participants Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Early Start Cohort D + ISIS 814907 115 mg n=5 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort C + ISIS 814907 60 mg n=9 Participants Participants from MAD Cohort C that were ISIS 814907 60 mg-treated or placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort D + ISIS 814907 115 mg n=12 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated or placebo-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
Time Taken to Reach Maximal Concentration (Tmax) of ISIS 814907 in Plasma	3.13 hours Interval 1.02 to 24.7	4.00 hours Interval 3.02 to 5.0	4.02 hours Interval 2.0 to 24.2	3.38 hours Interval 1.02 to 338.0	2.05 hours Interval 1.02 to 3.08	4.02 hours Interval 3.02 to 5.07	4.15 hours Interval 2.02 to 24.3	4.03 hours Interval 0.5 to 23.5

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, and 5 hours post-IT bolus injection on Day 85 in Part 1 and on Day 337 in Part 2

Outcome measures

Outcome measures
Measure	Part 1: Cohort A: ISIS 814907 10 mg n=6 Participants Participants received 10 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg n=6 Participants Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg n=9 Participants Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg n=13 Participants Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo n=2 Participants Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Early Start Cohort D + ISIS 814907 115 mg n=5 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort C + ISIS 814907 60 mg n=9 Participants Participants from MAD Cohort C that were ISIS 814907 60 mg-treated or placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort D + ISIS 814907 115 mg n=12 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated or placebo-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
Terminal Elimination Half-life (t1/2λz) of ISIS 814907 in Plasma	19.4 days Geometric Coefficient of Variation 62.7	38.0 days Geometric Coefficient of Variation 23.1	34.8 days Geometric Coefficient of Variation 22.6	42.5 days Geometric Coefficient of Variation 16.1	10.7 days Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable due to insufficient number of participants with events.	10.3 days Geometric Coefficient of Variation 8.99	10.6 days Geometric Coefficient of Variation 16.3	13.8 days Geometric Coefficient of Variation 54.0

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, and 5 hours post-IT bolus injection on Day 85 in Part 1 and on Day 337 in Part 2

Outcome measures

Outcome measures
Measure	Part 1: Cohort A: ISIS 814907 10 mg n=6 Participants Participants received 10 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg n=6 Participants Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg n=9 Participants Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg n=13 Participants Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo n=2 Participants Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Early Start Cohort D + ISIS 814907 115 mg n=5 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort C + ISIS 814907 60 mg n=9 Participants Participants from MAD Cohort C that were ISIS 814907 60 mg-treated or placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Cohort D + ISIS 814907 115 mg n=12 Participants Participants from MAD Cohort D that were ISIS 814907 115 mg-treated or placebo-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
Areas Under the Plasma Concentration-time Curve From Zero Time (Predose) to 24 Hours After the IT Administration (AUC0-24h) of ISIS 814907	679 nanogramhours per millilitre (ngh/mL) Geometric Coefficient of Variation 119	3638 nanogramhours per millilitre (ngh/mL) Geometric Coefficient of Variation 36.0	6143 nanogramhours per millilitre (ngh/mL) Geometric Coefficient of Variation 92.4	7120 nanogramhours per millilitre (ngh/mL) Geometric Coefficient of Variation 3066	10523 nanogramhours per millilitre (ngh/mL) Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable due to insufficient number of participants with events.	5176 nanogramhours per millilitre (ngh/mL) Geometric Coefficient of Variation 44.5	6396 nanogramhours per millilitre (ngh/mL) Geometric Coefficient of Variation 68.7	12542 nanogramhours per millilitre (ngh/mL) Geometric Coefficient of Variation 50.2

Adverse Events

Part 1: Cohort A: ISIS 814907 10 mg

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1: Cohort B: ISIS 814907 30 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1: Cohort C: ISIS 814907 60 mg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 1: Cohort D: ISIS 814907 115 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 1: Pooled Placebo

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 2: Late Start Cohort A + Cohort B + Cohort C + ISIS 814907 60 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2: Late Start Cohort D + ISIS 814907 115 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: Early Start Cohort A + ISIS 814907 60 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: Early Start Cohort B + ISIS 814907 60 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2: Early Start Cohort C + ISIS 814907 60 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 2: Early Start Cohort D + ISIS 814907 115 mg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Cohort A: ISIS 814907 10 mg n=6 participants at risk Participants received 10 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg n=6 participants at risk Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg n=9 participants at risk Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg n=13 participants at risk Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, ev(Q12W) on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo n=12 participants at risk Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Late Start Cohort A + Cohort B + Cohort C + ISIS 814907 60 mg n=4 participants at risk Participants from MAD Cohorts A, B, C that were placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Late Start Cohort D + ISIS 814907 115 mg n=4 participants at risk Participants from MAD Cohort D that were placebo-treated, received 115 mg ISIS 814907 diluted up in 20 mL artificial CSF, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort A + ISIS 814907 60 mg n=3 participants at risk Participants from MAD Cohort A that were ISIS 814907 10 mg -treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort B + ISIS 814907 60 mg n=5 participants at risk Participants from MAD Cohort B that were ISIS 814907 30 mg-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort C + ISIS 814907 60 mg n=7 participants at risk Participants from MAD Cohort C that were ISIS 814907 60 mg-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort D + ISIS 814907 115 mg n=10 participants at risk Participants from MAD Cohort D that were ISIS 814907 115 mg-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
Nervous system disorders Cerebrovascular accident	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Balance disorder	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Parkinsonism	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Aggression	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Paranoia	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Diverticulitis	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Part 1: Cohort A: ISIS 814907 10 mg n=6 participants at risk Participants received 10 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort B: ISIS 814907 30 mg n=6 participants at risk Participants received 30 mg ISIS 814907 diluted in 20 mL in artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort C: ISIS 814907 60 mg n=9 participants at risk Participants received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q4W on Days 1, 29, 57, and 85 in Part 1 of the study.	Part 1: Cohort D: ISIS 814907 115 mg n=13 participants at risk Participants received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, ev(Q12W) on Days 1 and 85 in Part 1 of the study.	Part 1: Pooled Placebo n=12 participants at risk Participants received 20 mL artificial CSF, intrathecally, as placebo on Days 1, 29, 57, and 85 for the 4-dose regimens, or on Days 1 and 85 for the 2-dose regimens in Part 1 of the study.	Part 2: Late Start Cohort A + Cohort B + Cohort C + ISIS 814907 60 mg n=4 participants at risk Participants from MAD Cohorts A, B, C that were placebo-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Late Start Cohort D + ISIS 814907 115 mg n=4 participants at risk Participants from MAD Cohort D that were placebo-treated, received 115 mg ISIS 814907 diluted up in 20 mL artificial CSF, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort A + ISIS 814907 60 mg n=3 participants at risk Participants from MAD Cohort A that were ISIS 814907 10 mg -treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort B + ISIS 814907 60 mg n=5 participants at risk Participants from MAD Cohort B that were ISIS 814907 30 mg-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort C + ISIS 814907 60 mg n=7 participants at risk Participants from MAD Cohort C that were ISIS 814907 60 mg-treated, received 60 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.	Part 2: Early Start Cohort D + ISIS 814907 115 mg n=10 participants at risk Participants from MAD Cohort D that were ISIS 814907 115 mg-treated, received 115 mg ISIS 814907 diluted in 20 mL artificial CSF, intrathecally, Q12W on Days 1, 85, 169, 253, and 337 in Part 2 of the study.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural pain	33.3% 2/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 3/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	15.4% 2/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	42.9% 3/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Vascular disorders Hypertension	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Vascular disorders Hypotension	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Vascular disorders Orthostatic hypotension	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
General disorders Fatigue	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	30.0% 3/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
General disorders Catheter site related reaction	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
General disorders Puncture site pain	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
General disorders Vaccination site bruising	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
General disorders Vessel puncture site bruise	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
General disorders Chest pain	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
General disorders Gait disturbance	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
General disorders General physical health deterioration	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
General disorders Peripheral swelling	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Atrophic vulvovaginitis	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Reproductive system and breast disorders Uterine inflammation	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Confusional state	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	23.1% 3/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 2/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Restlessness	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	15.4% 2/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 2/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Anxiety	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 2/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Hallucination	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Agitation	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Delirium	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 2/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Depression	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Aggression	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Delusion	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Disorientation	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Hallucination, visual	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Psychiatric disorders Sleep disorder	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Blood creatine phosphokinase increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Blood glucose increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Blood pressure increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations CSF cell count increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Cardiac murmur	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Albumin CSF increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 2/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations CSF protein increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 2/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Electrocardiogram QT prolonged	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 2/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Blood iron decreased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations C-reactive protein increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Electrophoresis protein abnormal	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Haematocrit decreased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Haemoglobin decreased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Haptoglobin increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Red blood cell count decreased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Serum ferritin increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Investigations Transferrin saturation decreased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Metabolism and nutrition disorders Vitamin B12 decreased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post lumbar puncture syndrome	50.0% 3/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	22.2% 2/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	23.1% 3/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 3/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 2/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Contusion	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Scratch	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Wound	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Conjunctival laceration	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Burns first degree	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Joint injury	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Pneumocephalus	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural headache	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Congenital, familial and genetic disorders Corneal dystrophy	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Headache	33.3% 2/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	50.0% 3/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 3/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	15.4% 2/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 3/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	40.0% 4/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	22.2% 2/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	42.9% 3/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Dizziness postural	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Balance disorder	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Decreased vibratory sense	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Dementia Alzheimer's type	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Disturbance in attention	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Myoclonus	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Paraesthesia	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Syncope	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Tension headache	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Tremor	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Head discomfort	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Nervous system disorders Posterior cortical atrophy	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Ear and labyrinth disorders Tinnitus	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Ear and labyrinth disorders Cerumen impaction	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Ear and labyrinth disorders Deafness bilateral	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Ear and labyrinth disorders Ear discomfort	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Ear and labyrinth disorders Hypoacusis	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo positional	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Eye disorders Dacryostenosis acquired	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Eye disorders Eye pain	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Eye disorders Lacrimation increased	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Eye disorders Vision blurred	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Eye disorders Visual impairment	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	22.2% 2/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 2/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 2/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Renal and urinary disorders Dysuria	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Renal and urinary disorders Urinary incontinence	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	22.2% 2/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	75.0% 3/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	40.0% 2/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	50.0% 5/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	50.0% 2/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	33.3% 1/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	28.6% 2/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	30.0% 3/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Myosclerosis	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 2/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Fungal skin infection	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Hordeolum	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Localised infection	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Lyme disease	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	11.1% 1/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Ophthalmic herpes simplex	16.7% 1/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	7.7% 1/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Periodontitis	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	8.3% 1/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Corona virus infection	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	25.0% 1/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	10.0% 1/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Borrelia infection	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	14.3% 1/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/6 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/9 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/13 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/12 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/4 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/3 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	20.0% 1/5 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/7 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.	0.00% 0/10 • From first dose of study drug up to Week 37 in Part 1 and up to Week 64 in Part 2 Safety population included all participants who were randomized and received at least 1 dose of study drug.

Additional Information

Ionis Pharmaceuticals, Inc.

Phone: 760-603-2346

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place