Trial Outcomes & Findings for Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants (NCT NCT03041116)

Last Updated: 2021-01-26

Results Overview

Change from baseline to Week 24 activities of daily living was assessed on the PKAN-ADL scale based on the Unified Parkinson's Disease Rating Scale (UPDRS) Part II. The PKAN-ADL is a validated measure of the participant's ability to complete ADL that are impacted by the diffuse motor manifestations of PKAN. It consists of 12 items related to activities of daily living, including eating, dressing, and walking. Each item has responses ranging from 0-4, with a higher value indicating greater disability in the given activity. To compute the total score, responses are summed across the 12 items. The available range of total scores on the PKAN-ADL scale was from 0 (no ADL affected) to 48 (ADL highly affected). The reported least square mean (LSM) was adjusted for baseline score and age group from the Type III analysis. A decrease in score indicates improvement in symptoms.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

84 participants

Primary outcome timeframe

Baseline (Day -1), Week 24

Results posted on

2021-01-26

Participant Flow

The study was conducted in Spain, United States, Canada, Czech Republic, France, Germany, Italy, Norway, and Poland from 17-July-2017 to 23-December-2019. A total of 91 participants were screened, of which 84 participants were randomized in the double blind period, and 78 participants completed the double-blind period.

The study consisted of a screening period of up to 29 days. All assessments at screening were done as per the schedule of assessments.

Participant milestones

Participant milestones
Measure	Fosmetpantotenate Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose 3 times daily (TID) from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.	Placebo Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.
Double-blind STARTED	41	43
Double-blind Received at Least 1 Dose of Study Drug	41	43
Double-blind COMPLETED	41	37
Double-blind NOT COMPLETED	0	6
Open-label STARTED	41	37
Open-label Received At Least 1 Dose of Study Drug	41	37
Open-label COMPLETED	0	0
Open-label NOT COMPLETED	41	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Fosmetpantotenate Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose 3 times daily (TID) from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.	Placebo Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.
Double-blind Death	0	2
Double-blind Withdrawal by Subject	0	4
Open-label Death	1	0
Open-label Termination of the study by Sponsor	39	37
Open-label Withdrawal by Subject	1	0

Baseline Characteristics

Efficacy and Safety Study of Fosmetpantotenate (RE-024) in PKAN Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fosmetpantotenate n=41 Participants Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.	Placebo n=43 Participants Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.	Total n=84 Participants Total of all reporting groups
Age, Continuous	22.6 years STANDARD_DEVIATION 10.61 • n=5 Participants	23.1 years STANDARD_DEVIATION 13.56 • n=7 Participants	22.9 years STANDARD_DEVIATION 12.14 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	24 Participants n=7 Participants	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	36 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day -1), Week 24

Population: Double-blind Full Analysis Set: any participant who received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Fosmetpantotenate n=41 Participants Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.	Placebo n=43 Participants Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.
Change From Baseline In The Pantothenate Kinase-Associated Neurodegeneration-Activities of Daily Living (PKAN-ADL) Total Score To The End Of The 24-week Double-blind Period	-1.3 units on a scale Standard Error 0.56	-1.3 units on a scale Standard Error 0.58

PRIMARY outcome

Timeframe: From Screening until end of Week 24

Population: Safety Population: any participant who received at least 1 dose of study drug during any period of the study.

An adverse event (AE) is any untoward medical occurrence associated with the use of the investigational product (IP; active or placebo) in a participant, without regard to possibility of causal relationship with IP. A serious adverse event (SAE) is an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of death from AE); persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious medical events. The TEAEs in the double-blind period are defined as AEs that are new or are a worsening of an existing condition that begins from day of first dose of IP until day after last dose for double-blind treatment period.

Outcome measures

Outcome measures
Measure	Fosmetpantotenate n=41 Participants Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.	Placebo n=43 Participants Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.
Number Of Participants With At Least 1 (≥1) Treatment-emergent Adverse Event (TEAE) And Treatment-emergent Serious Adverse Event (TESAE) During The 24-week Double-blind Period ≥1 TEAE	34 Participants	35 Participants
Number Of Participants With At Least 1 (≥1) Treatment-emergent Adverse Event (TEAE) And Treatment-emergent Serious Adverse Event (TESAE) During The 24-week Double-blind Period ≥1 TESAE	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1), Week 24

Population: Double-blind Full Analysis Set: any participant who received at least 1 dose of study drug.

The UPDRS is a comprehensive assessment of the burden and severity of signs and symptoms of Parkinsonism captured via systematic interview and neurological examination. The UPDRS-III is a standardized neurological examination that evaluates the performance of movements commonly affected in Parkinson's disease, PKAN, and other movement disorders. Part III of the UPDRS consists of 27 items, which correspond to 14 domains related to motor abilities such as tremor, stability, and bradykinesia. Each item has responses ranging from 0-4. To compute the UPDRS-III total score, responses are summed across the 27 items, and accordingly, range from 0-108. For domain totals, responses are summed across all of the items in a given domain (when domain corresponds to multiple items). An increase in score indicates greater disability. The reported LSM was adjusted for baseline score and age group from the Type III analysis.

Outcome measures

Outcome measures
Measure	Fosmetpantotenate n=41 Participants Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.	Placebo n=43 Participants Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required.
Absolute Change From Baseline In The UPDRS Part 3 (UPDRS-III) Total Score To The End Of The 24-week Double-blind Period	0.7 units on a scale Standard Deviation 5.25	-1.0 units on a scale Standard Deviation 6.81

Adverse Events

Fosmetpantotenate

Serious events: 9 serious events

Other events: 35 other events

Deaths: 1 deaths

Placebo

Serious events: 9 serious events

Other events: 25 other events

Deaths: 2 deaths

Fosmetpantotenate During Double-blind Period

Serious events: 8 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo During Double-blind Period

Serious events: 6 serious events

Other events: 35 other events

Deaths: 2 deaths

Fosmetpantotenate During Open-label Period

Serious events: 4 serious events

Other events: 25 other events

Deaths: 1 deaths

Placebo During Open-label Period

Serious events: 9 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fosmetpantotenate n=41 participants at risk Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required. Includes data over the entire study for those who completed the double-blind period and entered the open-label period.	Placebo n=37 participants at risk Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required. Includes data over the entire study for those who completed the double-blind period and entered the open-label period.	Fosmetpantotenate During Double-blind Period n=41 participants at risk Double-blind Period: each randomized participant received oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.	Placebo During Double-blind Period n=43 participants at risk Double-blind Period: each randomized participant received oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.	Fosmetpantotenate During Open-label Period n=41 participants at risk Open-label Period: at Week 25, all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.	Placebo During Open-label Period n=37 participants at risk Open-label Period: at Week 25, all participants started treatment with fosmetpantotenate according to the placebo-matched dose they were receiving at the end of the double-blind period. No dose escalation was required.
Injury, poisoning and procedural complications Fall	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Femur fracture	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Shunt malfunction	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Surgical and medical procedures Fracture treatment	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Cardiac disorders Tachycardia	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Aspiration	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Blood and lymphatic system disorders Anaemia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Dystonia	9.8% 4/41 • Number of events 6 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	10.8% 4/37 • Number of events 5 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	10.8% 4/37 • Number of events 5 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Headache	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Multiple sclerosis	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Depressed level of consciousness	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Hypotonia	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Nervous system disorder	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Seizure	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Disease progression	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Pain	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Pyrexia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Gait disturbance	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Vomiting	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Dysphagia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Faecaloma	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Nausea	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Skin lesion	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Metabolism and nutrition disorders Dehydration	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Skin Infections	4.9% 2/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Influenza	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Rhinovirus infection	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Tonsillitis streptococcal	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Tooth infection	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Urinary tract infection	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.

Other adverse events

Other adverse events
Measure	Fosmetpantotenate n=41 participants at risk Double-blind Period: each randomized participant received an oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required. Includes data over the entire study for those who completed the double-blind period and entered the open-label period.	Placebo n=37 participants at risk Double-blind Period: each randomized participant received an oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks. Open-label Period: all participants started treatment with fosmetpantotenate according to the placebo dose they were receiving at the end of the double-blind period. No dose escalation was required. Includes data over the entire study for those who completed the double-blind period and entered the open-label period.	Fosmetpantotenate During Double-blind Period n=41 participants at risk Double-blind Period: each randomized participant received oral dose of fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.	Placebo During Double-blind Period n=43 participants at risk Double-blind Period: each randomized participant received oral dose of placebo matched to fosmetpantotenate with dose escalation for Days 1 through 3, followed by the full dose TID from Day 4, based on the participant's age and weight at screening, for 24 weeks.	Fosmetpantotenate During Open-label Period n=41 participants at risk Open-label Period: at Week 25, all participants continued treatment with fosmetpantotenate according to the dose they were receiving at the end of the double-blind period. No dose escalation was required.	Placebo During Open-label Period n=37 participants at risk Open-label Period: at Week 25, all participants started treatment with fosmetpantotenate according to the placebo-matched dose they were receiving at the end of the double-blind period. No dose escalation was required.
Investigations Neutrophil count increased	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Nitrite urine present	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Platelet count increased	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Urine leukocyte esterase positive	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations White blood cell count decreased	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations White blood cell count increased	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Blood lactate dehydrogenase increased	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Blood urea increased	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Cortisol decreased	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Platelet count decreased	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations White blood cells urine positive	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Prothrombin time prolonged	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Urine leukocyte esterase	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Cardiac disorders Left ventricular hypertrophy	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Blood and lymphatic system disorders Leukopenia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Blood and lymphatic system disorders Normochromic normocytic anaemia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Cough	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Apnoea	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Pruritus	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Rash generalised	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.4% 1/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Productive cough	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Dystonia	17.1% 7/41 • Number of events 11 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	8.1% 3/37 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	14.6% 6/41 • Number of events 10 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	18.6% 8/43 • Number of events 9 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	8.1% 3/37 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Headache	9.8% 4/41 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	8.1% 3/37 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	11.6% 5/43 • Number of events 9 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	8.1% 3/37 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Oromandibular dystonia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Dizziness	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Paraesthesia	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Drooling	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Dyskinesia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Muscle spasticity	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Neuralgia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Migraine	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Nystagmus	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Sciatica	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Seizure	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Somnolence	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Multiple sclerosis	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Nerve compression	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Epilepsy	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Opisthotonus	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Parkinsonism	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Restless legs syndrome	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Nervous system disorders Hyperkinesia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Eye disorders Dark circles under eyes	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Eye disorders Eczema eyelids	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Eye disorders Optic atrophy	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Eye disorders Visual acuity reduced	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Eye disorders Dry eye	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Ear and labyrinth disorders Hypoacusis	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Diarrhoea	19.5% 8/41 • Number of events 11 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	12.2% 5/41 • Number of events 5 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	9.3% 4/43 • Number of events 6 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	7.3% 3/41 • Number of events 6 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Abdominal pain upper	12.2% 5/41 • Number of events 5 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	9.8% 4/41 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Vomiting	19.5% 8/41 • Number of events 12 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	9.8% 4/41 • Number of events 8 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	11.6% 5/43 • Number of events 6 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	9.8% 4/41 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Constipation	9.8% 4/41 • Number of events 5 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	7.3% 3/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Nausea	9.8% 4/41 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	16.3% 7/43 • Number of events 13 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Dyspepsia	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Abdominal pain	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Dry mouth	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Faecaloma	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Faeces soft	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Haematemesis	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Haematochezia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Hyperchlorhydria	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Parotid gland enlargement	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Salivary hypersecretion	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Tongue disorder	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Toothache	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Dysphagia	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Flatulence	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Gastrointestinal hypermotility	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Renal and urinary disorders Chromaturia	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Renal and urinary disorders Urine odour abnormal	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Rash	4.9% 2/41 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Dermal cyst	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Dermatitis diaper	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Ingrowing nail	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Lymphocyte count decreased	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Immune system disorders Hypersensitivity	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Immune system disorders Drug hypersensitivity	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Immune system disorders Seasonal allergy	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Pyrexia	17.1% 7/41 • Number of events 8 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	12.2% 5/41 • Number of events 6 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	9.3% 4/43 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Discomfort	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Fatigue	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Feeling cold	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Gait disturbance	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders General physical health deterioration	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Generalised oedema	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Medical device site inflammation	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Medical device site rash	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Chest pain	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Influenza like illness	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Oedema peripheral	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
General disorders Pain	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Psychiatric disorders Anxiety	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Psychiatric disorders Insomnia	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Psychiatric disorders Sleep disorder	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Psychiatric disorders Adjustment disorder with depressed mood	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Psychiatric disorders Restlessness	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Psychiatric disorders Affect lability	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Gastrostomy tube site complication	7.3% 3/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Laceration	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Fall	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Hand fracture	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Skin abrasion	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Arthropod bite	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Contusion	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Face injury	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Foetal exposure during pregnancy	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Limb injury	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Traumatic haemorrhage	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Wound	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Animal scratch	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Eyelid contusion	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Scar	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Traumatic fracture	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Injury, poisoning and procedural complications Joint dislocation	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Blood creatine phosphokinase increased	9.8% 4/41 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	9.8% 4/41 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Aspartate aminotransferase increased	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	8.1% 3/37 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	8.1% 3/37 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Weight decreased	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Haemoglobin decreased	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Activated partial thromboplastin time prolonged	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Alanine aminotransferase increased	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Bacterial test positive	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Blood cholesterol increased	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Blood glucose decreased	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Cardiac murmur	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Coagulation time prolonged	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Crystal urine present	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Culture throat positive	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Haemoglobin urine present	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Monocyte count increased	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Monocyte percentage increased	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Investigations Neutrophil count decreased	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Skin lesion	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Urticaria	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Acne	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Product Issues Product taste abnormal	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Product Issues Device failure	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Product Issues Device occlusion	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Musculoskeletal and connective tissue disorders Pain in extremity	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Musculoskeletal and connective tissue disorders Back pain	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Musculoskeletal and connective tissue disorders Knee deformity	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Musculoskeletal and connective tissue disorders Muscle spasms	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Musculoskeletal and connective tissue disorders Osteopenia	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Musculoskeletal and connective tissue disorders Posture abnormal	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Endocrine disorders Secondary adrenocortical insufficiency	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Metabolism and nutrition disorders Dehydration	7.3% 3/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Metabolism and nutrition disorders Iron deficiency	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Ear infection	7.3% 3/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	7.3% 3/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Upper respiratory tract infection	7.3% 3/41 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	7.3% 3/41 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Viral upper respiratory tract infection	12.2% 5/41 • Number of events 7 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	7.3% 3/41 • Number of events 4 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.7% 2/43 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Urinary tract infection	14.6% 6/41 • Number of events 6 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	12.2% 5/41 • Number of events 5 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	5.4% 2/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Bronchitis	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Genital candidiasis	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Respiratory tract infection	4.9% 2/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Skin infection	4.9% 2/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	4.9% 2/41 • Number of events 3 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Clostridium difficile infection	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Gastroenteritis	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Gastroenteritis viral	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Gastrointestinal infection	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Helminthic infection	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Influenza	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Oral candidiasis	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Oropharyngeal candidiasis	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Pharyngitis	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Stoma site infection	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Tooth infection	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Viral infection	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Vulvovaginal candidiasis	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.4% 1/41 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Cellulitis	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Herpes zoster	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Pneumonia influenzal	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Rhinitis	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/43 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Tonsillitis	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.7% 1/37 • Number of events 2 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.
Infections and infestations Ear lobe infection	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	2.3% 1/43 • Number of events 1 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/41 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.	0.00% 0/37 • From Screening until end of treatment (approximately 29 Months) The TEAEs in the double-blind period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP until the day after the last dose for the double-blind treatment period. The TEAEs in the open-label period were defined as AEs that were new or a worsening of an existing condition that began from the day of the first dose of IP received during the open-label period until 30 days after last dose for the open-label period.

Additional Information

Clinical Trial Information Desk

Retrophin, Inc.

Phone: +1-877-659-5518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Institution and Investigator agree that because the study is part of a multi-center study, any publication by the Institution/Investigator of the study results shall not be made before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER