Trial Outcomes & Findings for A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE) (NCT NCT03712228)

Last Updated: 2022-11-08

Results Overview

The time-normalized number of HAE attacks per month during Treatment Period 1 for a subject was calculated as the (number of HAE attacks / length of subject's evaluation period in days) \* 30.4375

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

44 participants

Primary outcome timeframe

13 weeks

Results posted on

2022-11-08

Participant Flow

Treatment Period 1 participants were assigned to 1 of 5 treatment arms. Treatment period 2 participants that completed Treatment Period 1 were assigned to either CSL312 (medium) or CSL312 (high) and could be up-titrated from CSL312 (medium) to CSL312 (med/high), if necessary. They were down-titrated from CSL312 (high) to CSL312 (medium). Only 2 subjects from the CSL312 (FXII/PLG HAE) arm were treated with CSL312 in Treatment Period 2.

Participant milestones

Participant milestones
Measure	Placebo Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency) receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency) receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency) receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency) receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency) receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (FXII/PLG HAE) Subjects with FXII/PLG HAE (Hereditary Angioedema with Normal C1-esterase Inhibitor and Factor XII or Plasminogen Gene Mutation) receiving high dose CSL312
Treatment Period 1 STARTED	8	9	8	7	6	6
Treatment Period 1 COMPLETED	8	9	8	7	6	5
Treatment Period 1 NOT COMPLETED	0	0	0	0	0	1
Treatment Period 2 STARTED	0	0	20	18	0	2
Treatment Period 2 COMPLETED	0	0	20	16	0	2
Treatment Period 2 NOT COMPLETED	0	0	0	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CSL312 (High) Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency) receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (FXII/PLG HAE) Subjects with FXII/PLG HAE (Hereditary Angioedema with Normal C1-esterase Inhibitor and Factor XII or Plasminogen Gene Mutation) receiving high dose CSL312
Treatment Period 1 Lack of Efficacy	0	1
Treatment Period 2 Pregnancy	1	0
Treatment Period 2 Withdrawal by Subject	1	0

Baseline Characteristics

A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=8 Participants Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency) receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency)receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency) receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency)receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 Participants Subjects with C1-INH HAE (Hereditary angioedema with C1-esterase inhibitor deficiency) receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (FXII/PLG HAE) n=6 Participants Subjects with FXII/PLG HAE (Hereditary Angioedema with Normal C1-esterase Inhibitor and Factor XII or Plasminogen Gene Mutation) receiving high dose CSL312	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	43 Participants n=115 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	27 Participants n=115 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	17 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	42 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	39 Participants n=115 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment Canada	1 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	7 participants n=115 Participants
Region of Enrollment United States	4 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	1 participants n=10 Participants	11 participants n=115 Participants
Region of Enrollment Israel	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	2 participants n=21 Participants	2 participants n=10 Participants	9 participants n=115 Participants
Region of Enrollment Germany	3 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	3 participants n=4 Participants	2 participants n=21 Participants	3 participants n=10 Participants	17 participants n=115 Participants

PRIMARY outcome

Timeframe: 13 weeks

Population: The Intent-to-Treat (ITT) population consisted of all subjects who provided informed consent, underwent any study screening procedure, and who were assigned to treatment in Treatment Period 1 or to treatment in Treatment Period 2, regardless of whether they received investigational product.

The time-normalized number of HAE attacks per month during Treatment Period 1 for a subject was calculated as the (number of HAE attacks / length of subject's evaluation period in days) \* 30.4375

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 Participants Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Mean Time Normalized Number of HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1	4.24 Number of HAE attacks per month Standard Deviation 1.801	0.48 Number of HAE attacks per month Standard Deviation 1.057	0.05 Number of HAE attacks per month Standard Deviation 0.127	0.35 Number of HAE attacks per month Standard Deviation 0.407	0.14 Number of HAE attacks per month Standard Deviation 0.222

SECONDARY outcome

Timeframe: 13 weeks

Population: ITT

Response is defined as a ≥ 50% relative reduction in the time-normalized number of HAE attacks (per month) during Treatment Period 1 compared to each subject's time-normalized number of HAE attacks (per month) during the Run-in Period

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 Participants Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Number of Responder Subjects With C1-INH HAE During Treatment Period 1	0 Number of participants	9 Number of participants	8 Number of participants	6 Number of participants	6 Number of participants

SECONDARY outcome

Timeframe: 13 weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 Participants Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Percentage of Responder Subjects With C1-INH HAE During Treatment Period 1	0 percentage of participants	100.0 percentage of participants	100.0 percentage of participants	85.7 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: 13 weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 Participants Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Number of HAE Attack-free Subjects With C1-INH HAE During Treatment Period 1	0 Number of participants	5 Number of participants	7 Number of participants	3 Number of participants	4 Number of participants

SECONDARY outcome

Timeframe: 13 weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 Participants Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Percentage of HAE Attack-free Subjects With C1-INH HAE During Treatment Period 1	0 percentage of participants	55.6 percentage of participants	87.5 percentage of participants	42.9 percentage of participants	66.7 percentage of participants

SECONDARY outcome

Timeframe: 13 weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=95 Total Number of HAE Attacks Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=12 Total Number of HAE Attacks Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=1 Total Number of HAE Attacks Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Total Number of HAE Attacks Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=2 Total Number of HAE Attacks Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Number of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1 Severe	20 Number of HAE attacks	0 Number of HAE attacks	0 Number of HAE attacks	1 Number of HAE attacks	0 Number of HAE attacks
The Number of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1 Mild	32 Number of HAE attacks	3 Number of HAE attacks	0 Number of HAE attacks	2 Number of HAE attacks	2 Number of HAE attacks
The Number of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1 Moderate	43 Number of HAE attacks	9 Number of HAE attacks	1 Number of HAE attacks	4 Number of HAE attacks	0 Number of HAE attacks

SECONDARY outcome

Timeframe: 13 weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=95 Total Number of HAE Attacks Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=12 Total Number of HAE Attacks Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=1 Total Number of HAE Attacks Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Total Number of HAE Attacks Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=2 Total Number of HAE Attacks Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Percentage of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1 Mild	33.7 percentage of HAE attacks	25.0 percentage of HAE attacks	0 percentage of HAE attacks	28.6 percentage of HAE attacks	100.0 percentage of HAE attacks
The Percentage of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1 Moderate	45.3 percentage of HAE attacks	75.0 percentage of HAE attacks	100.0 percentage of HAE attacks	57.1 percentage of HAE attacks	0 percentage of HAE attacks
The Percentage of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1 Severe	21.1 percentage of HAE attacks	0 percentage of HAE attacks	0 percentage of HAE attacks	14.3 percentage of HAE attacks	0 percentage of HAE attacks

SECONDARY outcome

Timeframe: 13 weeks

Population: ITT

The time-normalized number of HAE attacks per month during Treatment Period 1 for a subject was calculated as the (number of HAE attacks / length of subject's evaluation period in days) \* 30.4375

Outcome measures

Outcome measures
Measure	Placebo n=95 Total number of HAE attacks Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=12 Total number of HAE attacks Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=1 Total number of HAE attacks Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Total number of HAE attacks Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=2 Total number of HAE attacks Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Mean Time-normalized Number of Mild, Moderate or Severe HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1 Mild	1.42 Number of HAE attacks per month Standard Deviation 1.395	0.12 Number of HAE attacks per month Standard Deviation 0.177	0.0 Number of HAE attacks per month Standard Deviation 0.000	0.10 Number of HAE attacks per month Standard Deviation 0.168	0.14 Number of HAE attacks per month Standard Deviation 0.222
The Mean Time-normalized Number of Mild, Moderate or Severe HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1 Moderate	1.93 Number of HAE attacks per month Standard Deviation 1.403	0.36 Number of HAE attacks per month Standard Deviation 1.087	0.05 Number of HAE attacks per month Standard Deviation 0.127	0.20 Number of HAE attacks per month Standard Deviation 0.347	0.0 Number of HAE attacks per month Standard Deviation 0.000
The Mean Time-normalized Number of Mild, Moderate or Severe HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1 Severe	0.89 Number of HAE attacks per month Standard Deviation 1.365	0.0 Number of HAE attacks per month Standard Deviation 0.000	0.0 Number of HAE attacks per month Standard Deviation 0.000	0.05 Number of HAE attacks per month Standard Deviation 0.136	0.0 Number of HAE attacks per month Standard Deviation 0.000

SECONDARY outcome

Timeframe: 13 weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 Participants Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Number of Subjects With at Least One (1) HAE Attack Treated With On-demand HAE Medication, in Subjects With C1-INH HAE During Treatment Period 1	8 Number of participants	3 Number of participants	1 Number of participants	2 Number of participants	0 Number of participants

SECONDARY outcome

Timeframe: 13 weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 Participants Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Percentage of Subjects With at Least One (1) HAE Attack Treated With On-demand HAE Medication, in Subjects With C1-INH HAE During Treatment Period 1	100.0 percentage of participants	33.3 percentage of participants	12.5 percentage of participants	28.6 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 13 weeks

Population: The pharmacokinetic (PK) population consisted of all subjects in the Safety population for whom at least 1 measurable concentration of CSL312 was reported.

Outcome measures

Outcome measures
Measure	Placebo Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Maximum Concentration (Cmax) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1	—	10.6 ug/mL Standard Deviation 6.09	15.9 ug/mL Standard Deviation 5.22	56.4 ug/mL Standard Deviation 15.9	—

SECONDARY outcome

Timeframe: 13 weeks

Population: PK

Outcome measures

Outcome measures
Measure	Placebo Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Area Under the Concentration-time Curve in 1 Dosing Interval (AUC0-tau) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1	—	4507 h*μg/mL Standard Deviation 2424	7166 h*μg/mL Standard Deviation 2410	26514 h*μg/mL Standard Deviation 8151	—

SECONDARY outcome

Timeframe: 13 weeks

Population: PK

Outcome measures

Outcome measures
Measure	Placebo Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Time of Maximum Concentration (Tmax) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1	—	143.38 hours Interval 45.4 to 196.0	165.51 hours Interval 116.0 to 218.0	165.63 hours Interval 72.4 to 188.0	—

SECONDARY outcome

Timeframe: 13 weeks

Population: PK

Outcome measures

Outcome measures
Measure	Placebo Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=7 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=7 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=5 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Terminal Elimination Half-life (T1/2) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1	—	411.7 hours Standard Deviation 96.97	394.0 hours Standard Deviation 85.64	443.5 hours Standard Deviation 44.00	—

SECONDARY outcome

Timeframe: 13 weeks

Population: PK

Outcome measures

Outcome measures
Measure	Placebo Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Clearance (CL/F) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1	—	0.0198 L/hour Standard Deviation 0.0079	0.0303 L/hour Standard Deviation 0.0084	0.0246 L/hour Standard Deviation 0.0079	—

SECONDARY outcome

Timeframe: 13 weeks

Population: PK

Outcome measures

Outcome measures
Measure	Placebo Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=7 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=7 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=5 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Volume of Distribution During the Elimination Phase (Vz/F) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1	—	10.6 Liters Standard Deviation 5.10	17.0 Liters Standard Deviation 4.78	17.1 Liters Standard Deviation 6.67	—

SECONDARY outcome

Timeframe: 13 weeks

Population: The Safety population (SP) consisted of all subjects who provided informed consent, were assigned to treatment in Treatment Period 1 or to treatment in Treatment Period 2 and received at least 1 dose or partial dose of investigational product and was based on the actual treatment received.

Adverse events of special interest is defined as anaphylaxis, thromboembolic events, and bleeding events.

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 Participants Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 Participants Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 Participants Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 Participants Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
The Number of Subjects With C1-INH HAE With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), Injection Site Reactions (ISRs), Binding Antibodies to CSL312 During Treatment Period 1 AESI	1 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants
The Number of Subjects With C1-INH HAE With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), Injection Site Reactions (ISRs), Binding Antibodies to CSL312 During Treatment Period 1 AEs	7 Number of participants	7 Number of participants	7 Number of participants	7 Number of participants	4 Number of participants
The Number of Subjects With C1-INH HAE With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), Injection Site Reactions (ISRs), Binding Antibodies to CSL312 During Treatment Period 1 SAEs	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants
The Number of Subjects With C1-INH HAE With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), Injection Site Reactions (ISRs), Binding Antibodies to CSL312 During Treatment Period 1 ISRs	2 Number of participants	1 Number of participants	1 Number of participants	4 Number of participants	2 Number of participants
The Number of Subjects With C1-INH HAE With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), Injection Site Reactions (ISRs), Binding Antibodies to CSL312 During Treatment Period 1 Binding Antibodies to CSL312	1 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants	0 Number of participants

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=8 participants at risk Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 participants at risk Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 participants at risk Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 participants at risk Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 participants at risk Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med-Period 2) n=36 participants at risk Subjects with C1-INH HAE receiving medium dose CSL312	CSL312 (Med/High-Period 2) n=3 participants at risk Subjects with C1-INH HAE receiving medium/high dose CSL312	CSL312 (High-Period 2) n=18 participants at risk Subjects with C1-INH HAE receiving high dose CSL312	CSL312 (FXII/PLG HAE-Period 1) n=6 participants at risk Subjects with FXII/PLG HAE (Hereditary Angioedema with Normal C1-esterase Inhibitor and Factor XII or Plasminogen Gene Mutation) receiving high dose CSL312	CSL312 (FXII/PLG HAE-Period 2) n=2 participants at risk Subjects with FXII/PLG HAE (Hereditary Angioedema with Normal C1-esterase Inhibitor and Factor XII or Plasminogen Gene Mutation) receiving high dose CSL312
Gastrointestinal disorders Diverticular perforation	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Congenital, familial and genetic disorders Hereditary angioedema	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 1/6 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.

Other adverse events

Other adverse events
Measure	Placebo n=8 participants at risk Subjects with C1-INH HAE receiving buffer only Placebo: Buffer without active ingredient	CSL312 (Low) n=9 participants at risk Subjects with C1-INH HAE receiving low dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med) n=8 participants at risk Subjects with C1-INH HAE receiving medium dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (High) n=7 participants at risk Subjects with C1-INH HAE receiving high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med/High) n=6 participants at risk Subjects with C1-INH HAE receiving medium/high dose CSL312 Factor XIIa antagonist monoclonal antibody: Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use	CSL312 (Med-Period 2) n=36 participants at risk Subjects with C1-INH HAE receiving medium dose CSL312	CSL312 (Med/High-Period 2) n=3 participants at risk Subjects with C1-INH HAE receiving medium/high dose CSL312	CSL312 (High-Period 2) n=18 participants at risk Subjects with C1-INH HAE receiving high dose CSL312	CSL312 (FXII/PLG HAE-Period 1) n=6 participants at risk Subjects with FXII/PLG HAE (Hereditary Angioedema with Normal C1-esterase Inhibitor and Factor XII or Plasminogen Gene Mutation) receiving high dose CSL312	CSL312 (FXII/PLG HAE-Period 2) n=2 participants at risk Subjects with FXII/PLG HAE (Hereditary Angioedema with Normal C1-esterase Inhibitor and Factor XII or Plasminogen Gene Mutation) receiving high dose CSL312
Infections and infestations Tonsillitis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Oral herpes	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 5 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 4 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Pharyngitis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 1/9 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Upper respiratory tract infection	25.0% 2/8 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	22.2% 2/9 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	37.5% 3/8 • Number of events 3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 4/36 • Number of events 4 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Nasopharyngitis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	25.0% 2/8 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	8.3% 3/36 • Number of events 6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 3/18 • Number of events 4 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Abscess limb	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 1/9 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Cellulitis	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Gastroenteritis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 1/9 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Gingivitis	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Nasal herpes	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Urinary tract infection	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 4 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Sinusitis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 2/18 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Cystitis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Hordeolum	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Pneumonia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	33.3% 1/3 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	33.3% 1/3 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Bronchitis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Injection site erythema	25.0% 2/8 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 3/18 • Number of events 6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Injection site pain	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	42.9% 3/7 • Number of events 3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 1/6 • Number of events 4 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Chest discomfort	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	28.6% 2/7 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Injection site pruritus	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Pyrexia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Fatigue	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 2/18 • Number of events 4 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Injection site reaction	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 1/9 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 1/6 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 1/6 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Plantar fascial fibromatosis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 1/9 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Injection site swelling	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Injection site urticaria	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 1/6 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Chest pain	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Chills	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Facial pain	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Gastrointestinal disorders Nausea	25.0% 2/8 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 2/18 • Number of events 3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 1/6 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 1/9 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	13.9% 5/36 • Number of events 7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	33.3% 1/3 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Gastrointestinal disorders Gastritis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 2/18 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Gastrointestinal disorders Toothache	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 2/18 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Gastrointestinal disorders Inguinal hernia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Gastrointestinal disorders Dental caries	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	28.6% 2/7 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 1/9 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 1/9 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Skin and subcutaneous tissue disorders Polymorphic light eruption	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Nervous system disorders Headache	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	28.6% 2/7 • Number of events 3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	33.3% 2/6 • Number of events 5 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 6/36 • Number of events 12 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	22.2% 4/18 • Number of events 4 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Nervous system disorders Dizziness	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Nervous system disorders Nerve compression	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Nervous system disorders Sciatica	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Nervous system disorders Paraesthesia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Nervous system disorders Anosmia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Back pain	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 2/18 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Patellofemoral pain syndrome	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 1/9 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 1/6 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	8.3% 3/36 • Number of events 3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 1/6 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	22.2% 4/18 • Number of events 4 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	8.3% 3/36 • Number of events 4 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Torticollis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Bone swelling	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Injury, poisoning and procedural complications Contusion	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 1/9 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Injury, poisoning and procedural complications Vascular access site bruising	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Injury, poisoning and procedural complications Limb injury	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 1/6 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	16.7% 3/18 • Number of events 3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Psychiatric disorders Initial insomnia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	12.5% 1/8 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Psychiatric disorders Insomnia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Psychiatric disorders Anxiety	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	11.1% 2/18 • Number of events 4 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Immune system disorders Food allergy	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Renal and urinary disorders Renal pain	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	14.3% 1/7 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Renal and urinary disorders Nephrolithiasis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Renal and urinary disorders Ureterolithiasis	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Vascular disorders Hot flush	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Vascular disorders Hypertension	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Investigations SARS-CoV-2 test positive	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Investigations Glycosylated haemoglobin increased	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	2.8% 1/36 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Social circumstances Pregnancy of partner	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 2/36 • Number of events 2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Cardiac disorders Palpitations	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Eye disorders Photopsia	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	5.6% 1/18 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/2 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations COVID-19	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	100.0% 2/2 • Number of events 5 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Herpes zoster	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Infections and infestations Influenza	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
General disorders Malaise	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Renal and urinary disorders Dysuria	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/9 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/8 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/7 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/36 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/3 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/18 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	0.00% 0/6 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.	50.0% 1/2 • Number of events 1 • Approximately 129 weeks per participant Adverse events were collected for both Treatment Periods 1 (up to 13 weeks) and 2 (up to 44 weeks + up to 13 weeks follow-up). Adverse events will be reported by Treatment Period.

Additional Information

Study Director

CSL Behring

Phone: 610-878-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place