Trial Outcomes & Findings for First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221 (NCT NCT02675465)

Last Updated: 2025-10-23

Results Overview

Number of subjects with TEAE, TESAE, and AE leading to discontinuation during the 2 year treatment period and extension (Stage 3 and 4 combined)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

29 participants

Primary outcome timeframe

Stage 3 (2 year treatment) and Stage 4 (Extension) combined, (mean = 71 months on treatment)

Results posted on

2025-10-23

Participant Flow

The study was conducted in 4 stages and 4 cohorts, with Stages 1 and 2 only for Cohort 1 and Stages 3 and 4 for all 4 cohorts.

Participant milestones

Participant milestones
Measure	Cohort 1 (ERT Experienced; Ambulatory): SAD 5 to 20 mg/kg ATB200 ERT experienced ambulatory subjects receiving single ascending dose (SAD) of ATB200 (5 mg/kg, 10 mg/kg, and 20 mg/kg)	Cohort 1 (ERT Experienced; Ambulatory) MAD 20 mg/kg ATB200 + 130 to 260 mg AT2221 Enzyme replacement therapy (ERT)-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received 20 mg ATB200 in combination with 130 or 260 mg AT2221	Cohort 1 (ERT Experienced; Ambulatory): ERT experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received 20 mg ATB200 in combination with 260 mg AT2221	Cohort 2 (ERT Experienced; Non-ambulatory): 20 mg/kg ATB200 + 260 mg AT2221 ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received 20 mg ATB200 in combination with 260 mg of AT2221	Cohort 3 (ERT Naive; Ambulatory): 20 mg/kg ATB200 + 260 mg AT2221 ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received 20 mg ATB200 in combination with 260 mg of AT2221	Cohort 4 (ERT Experienced; Ambulatory): 20 mg/kg ATB200 + 260 mg AT2221 ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received 20 mg ATB200 in combination with 260 mg AT2221
Stage 1 SAD (Cohort 1 Only) STARTED	11	0	0	0	0	0
Stage 1 SAD (Cohort 1 Only) COMPLETED	11	0	0	0	0	0
Stage 1 SAD (Cohort 1 Only) NOT COMPLETED	0	0	0	0	0	0
Stage 2 MAD (Cohort 1 Only) STARTED	0	11	0	0	0	0
Stage 2 MAD (Cohort 1 Only) COMPLETED	0	11	0	0	0	0
Stage 2 MAD (Cohort 1 Only) NOT COMPLETED	0	0	0	0	0	0
Stage 3: 2 Year Treatment STARTED	0	0	11	6	6	6
Stage 3: 2 Year Treatment COMPLETED	0	0	9	5	6	6
Stage 3: 2 Year Treatment NOT COMPLETED	0	0	2	1	0	0
Stage 4: Long Term Extension STARTED	0	0	9	5	6	6
Stage 4: Long Term Extension COMPLETED	0	0	8	4	6	6
Stage 4: Long Term Extension NOT COMPLETED	0	0	1	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (ERT Experienced; Ambulatory): ERT experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received 20 mg ATB200 in combination with 260 mg AT2221	Cohort 2 (ERT Experienced; Non-ambulatory): 20 mg/kg ATB200 + 260 mg AT2221 ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received 20 mg ATB200 in combination with 260 mg of AT2221
Stage 3: 2 Year Treatment Adverse Event	1	1
Stage 3: 2 Year Treatment Withdrawal by Subject	1	0
Stage 4: Long Term Extension Physician Decision	1	0
Stage 4: Long Term Extension Death	0	1

Baseline Characteristics

First-In-Human Study to Evaluate Safety, Tolerability, and PK of Intravenous ATB200 Alone and When Co-Administered With Oral AT2221

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=11 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6-minute walk test (6MWT)	Cohort 2 n=6 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment	Cohort 3 n=6 Participants ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT	Cohort 4 n=6 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=39 Participants	6 Participants n=41 Participants	5 Participants n=35 Participants	5 Participants n=31 Participants	26 Participants n=146 Participants
Age, Categorical >=65 years	1 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants	1 Participants n=31 Participants	3 Participants n=146 Participants
Sex: Female, Male Female	2 Participants n=39 Participants	2 Participants n=41 Participants	5 Participants n=35 Participants	4 Participants n=31 Participants	13 Participants n=146 Participants
Sex: Female, Male Male	9 Participants n=39 Participants	4 Participants n=41 Participants	1 Participants n=35 Participants	2 Participants n=31 Participants	16 Participants n=146 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=39 Participants	3 Participants n=41 Participants	1 Participants n=35 Participants	5 Participants n=31 Participants	17 Participants n=146 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=39 Participants	3 Participants n=41 Participants	5 Participants n=35 Participants	1 Participants n=31 Participants	12 Participants n=146 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants
Race (NIH/OMB) White	8 Participants n=39 Participants	3 Participants n=41 Participants	1 Participants n=35 Participants	5 Participants n=31 Participants	17 Participants n=146 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=39 Participants	3 Participants n=41 Participants	5 Participants n=35 Participants	1 Participants n=31 Participants	12 Participants n=146 Participants
Years since diagnosis with Pompe disease	7.7 years STANDARD_DEVIATION 5.11 • n=39 Participants	15.9 years STANDARD_DEVIATION 13.08 • n=41 Participants	5.2 years STANDARD_DEVIATION 4.70 • n=35 Participants	13.0 years STANDARD_DEVIATION 4.30 • n=31 Participants	10.0 years STANDARD_DEVIATION 7.98 • n=146 Participants

PRIMARY outcome

Timeframe: Stage 3 (2 year treatment) and Stage 4 (Extension) combined, (mean = 71 months on treatment)

Number of subjects with TEAE, TESAE, and AE leading to discontinuation during the 2 year treatment period and extension (Stage 3 and 4 combined)

Outcome measures

Outcome measures
Measure	Cohort 1 n=11 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 2 n=6 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 3 n=6 Participants ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 4 n=6 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug Number of subjects with TEAEs	11 Participants	6 Participants	6 Participants	6 Participants
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug Number of subjects with TESAEs	7 Participants	4 Participants	4 Participants	6 Participants
Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Adverse Events (AEs) Leading to Discontinuation of Study Drug Number of subjects with AEs leading to discontinuation	1 Participants	2 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 18 Weeks

Population: Pharmacokinetic (PK) analysis only performed in Cohort 1 and Cohort 3. One subject each in Cohort 1 and Cohort 3 did not have PK sample available following first dose.

Plasma GAA levels (Cmax) measured in Cohorts 1 and 3 following 1st and 3rd doses of cipaglucosidase alfa + miglustat

Outcome measures

Outcome measures
Measure	Cohort 1 n=11 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 2 n=6 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 3 ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 4 ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
Plasma Human Acid α-glucosidase (GAA) Activity Levels as Measured by Maximum Observed Plasma Concentration (Cmax). Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (1st dose)	108836 nmol/mL/hr Geometric Coefficient of Variation 20.5	132400 nmol/mL/hr Geometric Coefficient of Variation 14.3	—	—
Plasma Human Acid α-glucosidase (GAA) Activity Levels as Measured by Maximum Observed Plasma Concentration (Cmax). Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (3rd dose)	119624 nmol/mL/hr Geometric Coefficient of Variation 25.7	105842 nmol/mL/hr Geometric Coefficient of Variation 15.4	—	—

PRIMARY outcome

Timeframe: 18 Weeks

Population: PK analysis only performed in Cohort 1 and Cohort 3. One subject each in Cohort 1 and Cohort 3 did not have PK sample available following first dose.

Plasma GAA levels (Tmax) measured in Cohorts 1 and 3 following 1st and 3rd doses of cipaglucosidase alfa + miglustat

Outcome measures

Outcome measures
Measure	Cohort 1 n=11 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 2 n=6 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 3 ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 4 ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
Plasma GAA Activity Levels as Measured by Time to Reach the Maximum Observed Plasma Concentration (Tmax). Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (1st Dose)	3.49 h Interval 3.47 to 4.0	3.97 h Interval 3.47 to 4.0	—	—
Plasma GAA Activity Levels as Measured by Time to Reach the Maximum Observed Plasma Concentration (Tmax). Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (3rd Dose)	3.57 h Interval 3.35 to 4.0	3.66 h Interval 3.5 to 3.98	—	—

PRIMARY outcome

Timeframe: 18 Weeks

Population: PK analysis only performed in Cohort 1 and Cohort 3. One subject each in Cohort 1 and Cohort 3 did not have PK sample available following first dose.

Plasma GAA levels (AUC) measured in Cohorts 1 and 3 following 1st and 3rd doses of cipaglucosidase alfa + miglustat

Outcome measures

Outcome measures
Measure	Cohort 1 n=11 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 2 n=6 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 3 ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 4 ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
Plasma GAA Activity Levels as Measured by Area Under the Plasma Drug Concentration-time Curve (AUC). Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (1st Dose)	608180 nmol*hr/mL Geometric Coefficient of Variation 23.7	762484 nmol*hr/mL Geometric Coefficient of Variation 22.0	—	—
Plasma GAA Activity Levels as Measured by Area Under the Plasma Drug Concentration-time Curve (AUC). Cipaglucosidase alfa 20 mg/kg + miglustat 260 mg (3rd Dose)	670754 nmol*hr/mL Geometric Coefficient of Variation 29.4	638984 nmol*hr/mL Geometric Coefficient of Variation 18.1	—	—

SECONDARY outcome

Timeframe: Baseline, Month 60

Population: Motor function was evaluated using the Efficacy Population (consisting of subjects who took at least 1 dose of study drug (20 mg/kg cipaglucosidase alfa + 260 mg miglustat) and had both a baseline and at least 1 post-baseline assessment for any efficacy endpoint. 6-minute walk distance (6MWD) was only performed in ambulatory subjects (Cohorts 1, 3, and 4). Baseline and Month 60 assessment available for 9 subjects in Cohort 1, 6 subjects in Cohort 3, and 4 subjects in Cohort 4.

Motor function was measured in ambulatory subjects using 6MWD (meters).

Outcome measures

Outcome measures
Measure	Cohort 1 n=9 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 2 n=6 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 3 n=4 Participants ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 4 ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
Change From Baseline in 6-minute Walk Distance (6MWD)	9.2 meters Standard Deviation 49.89	-34.9 meters Standard Deviation 118.80	27.7 meters Standard Deviation 74.5	—

SECONDARY outcome

Timeframe: Baseline, Month 60

Population: Number of participants analyzed per cohort represents the number of subjects assessed at the specific visit for the parameter. Eight subjects in Cohort 1, 1 subject in Cohort 2, and 5 subjects in Cohort 4 had FVC values reported at Month 60.

Pulmonary function was measured by sitting and supine % predicted forced vital capacity (FVC)

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 2 n=1 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 3 n=6 Participants ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 4 n=5 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
Change From Baseline in Pulmonary Function Tests Sitting % predicted FVC: Change from Baseline to Month 60	-2.8 percent predicted FVC Standard Deviation 10.93	-8.0 percent predicted FVC Standard Deviation 0	5.0 percent predicted FVC Standard Deviation 8.07	3.8 percent predicted FVC Standard Deviation 3.27
Change From Baseline in Pulmonary Function Tests Supine % predicted FVC: Change from Baseline to Month 60	0.8 percent predicted FVC Standard Deviation 7.59	-1.0 percent predicted FVC Standard Deviation 0	1.2 percent predicted FVC Standard Deviation 9.34	5.5 percent predicted FVC Standard Deviation 5.80

SECONDARY outcome

Timeframe: Baseline, Month 60

Population: Total MMT score was evaluated using the Efficacy Population consisting of all enrolled subjects who took at least 1 dose of study drug (20 mg/kg cipaglucosidase alfa + 260 mg miglustat co-administration) in Stage 3 and had both a baseline and at least 1 post-baseline assessment for any efficacy endpoint. Number of participants analyzed per cohort represents the number of subjects assessed at the specific visit for the parameter.

Muscle strength was measured by total manual muscle test (MMT) score. Total MMT score ranges from 0 to 80 based on all 16 muscle groups, which are right/left shoulder abduction, right/left shoulder adduction, right/left elbow flexion, right/left elbow extension, right/left hip flexion, right/left hip abduction, right/left knee flexion, and right/left knee extension. Higher scores indicate less disease impact on muscle functions.

Outcome measures

Outcome measures
Measure	Cohort 1 n=7 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 2 n=3 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 3 n=5 Participants ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 4 n=5 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
Change From Baseline in Muscle Strength Tests	2.0 score on a scale Standard Deviation 5.20	0.0 score on a scale Standard Deviation 4.36	1.0 score on a scale Standard Deviation 3.54	3.4 score on a scale Standard Deviation 4.83

SECONDARY outcome

Timeframe: Baseline, Month 60

Population: The Efficacy Population consists of all enrolled subjects who took at least 1 dose of study drug (20 mg/kg cipaglucosidase alfa + 260 mg miglustat co-administration) in Stage 3 and had both a baseline and at least 1 post-baseline assessment for any efficacy endpoint. Number of participants analyzed for FSS are those in each cohort who completed the assessment at baseline and Month 60.

The Fatigue Severity Score (FSS) consists of 9 questions, each scored on a scale from 1 ("completely disagree") to 7 ("completely agree"). The total score ranges from 9 to 63, with higher values representing higher level of fatigue due to the disease condition.

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 2 n=3 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 3 n=6 Participants ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 4 n=4 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
Change From Baseline in Fatigue Severity Score (FSS)	0.9 score on a scale Standard Deviation 11.48	-4.3 score on a scale Standard Deviation 7.23	-0.5 score on a scale Standard Deviation 8.67	-14.0 score on a scale Standard Deviation 15.25

SECONDARY outcome

Timeframe: Baseline, Month 60

Population: Number of participants analyzed per cohort represents the number of subjects assessed at the specific visit for the parameter. Eight subjects in Cohort 1, 2 subjects in Cohort 2, and 5 subjects in Cohort 4 had SGIC values reported at Month 60.

The Subject's Global Impression of Change overall physical wellbeing (question 1) is scored on a 7-point rating scale. Improved = response of 5 or higher, No change = response of 4, and Declined = response of 3 or lower.

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 2 n=2 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 3 n=6 Participants ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 4 n=5 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
Change From Baseline in Overall Physical Wellbeing (Subject's Global Impression of Change [SGIC], Question1) Improved	3 Participants	0 Participants	3 Participants	4 Participants
Change From Baseline in Overall Physical Wellbeing (Subject's Global Impression of Change [SGIC], Question1) No change	2 Participants	2 Participants	1 Participants	0 Participants
Change From Baseline in Overall Physical Wellbeing (Subject's Global Impression of Change [SGIC], Question1) Declined	3 Participants	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Month 60

Population: Number of participants analyzed per cohort represents the number of subjects assessed at the specific visit for the parameter. Eight subjects in Cohort 1, 3 subjects in Cohort 2, and 5 subjects in Cohort 4 had PGIC values reported at Month 60.

The Physician's Global Impression of Change overall physical wellbeing is scored on a 7-point rating scale. Improved = response of 5 or higher, No change = response of 4, and Declined = response of 3 or lower.

Outcome measures

Outcome measures
Measure	Cohort 1 n=8 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 2 n=3 Participants ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 3 n=6 Participants ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.	Cohort 4 n=5 Participants ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg during the study.
Change From Baseline in Overall Physical Wellbeing (Physician's Global Impression of Change [PGIC]) Declined	3 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in Overall Physical Wellbeing (Physician's Global Impression of Change [PGIC]) Improved	2 Participants	1 Participants	2 Participants	2 Participants
Change From Baseline in Overall Physical Wellbeing (Physician's Global Impression of Change [PGIC]) No change	3 Participants	2 Participants	4 Participants	3 Participants

Adverse Events

Cohort 1: ATB200 5 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 1: ATB 200 10 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 1: ATB200 20 mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 1: ATB200 20 mg + 130/260 mg Miglustat

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Cohort 1 ATB200 20 mg/kg + Miglustat 260 mg

Serious events: 7 serious events

Other events: 11 other events

Deaths: 0 deaths

Cohort 2 ATB200 20 mg/kg + Miglustat 260 mg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 1 deaths

Cohort 3 ATB200 20 mg/kg + Miglustat 260 mg

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 4 ATB200 20 mg/kg + Miglustat 260 mg

Serious events: 6 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: ATB200 5 mg n=11 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received single dose of ATB200 5 mg/kg in Stage 1	Cohort 1: ATB 200 10 mg n=11 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received single dose of ATB200 10 mg/kg in Stage 1	Cohort 1: ATB200 20 mg n=11 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received single dose of ATB200 20 mg/kg in Stage 1	Cohort 1: ATB200 20 mg + 130/260 mg Miglustat n=11 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 130 or 260 mg in Stage 2	Cohort 1 ATB200 20 mg/kg + Miglustat 260 mg n=11 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.	Cohort 2 ATB200 20 mg/kg + Miglustat 260 mg n=6 participants at risk ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.	Cohort 3 ATB200 20 mg/kg + Miglustat 260 mg n=6 participants at risk ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.	Cohort 4 ATB200 20 mg/kg + Miglustat 260 mg n=6 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.
Cardiac disorders Acute myocardial infarction	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Arrhythmia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Cardiac arrest	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Supraventricular tachycardia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Endocrine disorders Hypothyroidism	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Colitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Femoral hernia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Chills	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Peripheral swelling	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Pyrexia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations COVID-19	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Diverticulitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Lower respiratory tract infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Pneumonia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Postoperative wound infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Septic shock	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Urinary tract infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Limb injury	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Traumatic hematoma	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Presyncope	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Syncope	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Renal and urinary disorders Acute kidney injury	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Renal and urinary disorders Nephrolithiasis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Pharyngeal edema	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Flushing	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Hemorrhage	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Hypotension	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).

Other adverse events

Other adverse events
Measure	Cohort 1: ATB200 5 mg n=11 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received single dose of ATB200 5 mg/kg in Stage 1	Cohort 1: ATB 200 10 mg n=11 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received single dose of ATB200 10 mg/kg in Stage 1	Cohort 1: ATB200 20 mg n=11 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received single dose of ATB200 20 mg/kg in Stage 1	Cohort 1: ATB200 20 mg + 130/260 mg Miglustat n=11 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 130 or 260 mg in Stage 2	Cohort 1 ATB200 20 mg/kg + Miglustat 260 mg n=11 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for 2 to 6 years prior to enrollment and were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.	Cohort 2 ATB200 20 mg/kg + Miglustat 260 mg n=6 participants at risk ERT-experienced non-ambulatory subjects with Pompe disease who had been on ERT for at least 2 years prior to enrollment. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.	Cohort 3 ATB200 20 mg/kg + Miglustat 260 mg n=6 participants at risk ERT-naive ambulatory subjects with Pompe disease who were able to walk at least 200 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.	Cohort 4 ATB200 20 mg/kg + Miglustat 260 mg n=6 participants at risk ERT-experienced ambulatory subjects with Pompe disease who had been on ERT for at least 7 years prior to enrollment and were able to walk at least 75 meters in the 6MWT. Subjects received ATB200 20 mg/kg + miglustat 260 mg in Stage 3 and 4.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Flatulence	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 8 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Gait disturbance	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Wound	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Large intestine polyp	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Fall	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	54.5% 6/11 • Number of events 36 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	100.0% 6/6 • Number of events 43 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	66.7% 4/6 • Number of events 27 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Nasopharyngitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	81.8% 9/11 • Number of events 19 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	66.7% 4/6 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	54.5% 6/11 • Number of events 11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 10 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	83.3% 5/6 • Number of events 8 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Headache	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	36.4% 4/11 • Number of events 11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	66.7% 4/6 • Number of events 8 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	100.0% 6/6 • Number of events 15 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations COVID-19	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	45.5% 5/11 • Number of events 6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	66.7% 4/6 • Number of events 8 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Diarrhea	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	36.4% 4/11 • Number of events 12 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	66.7% 4/6 • Number of events 13 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	54.5% 6/11 • Number of events 8 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Fatigue	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	27.3% 3/11 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	83.3% 5/6 • Number of events 13 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Urinary tract infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 7 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 13 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 8 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	27.3% 3/11 • Number of events 13 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 8 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Contusion	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	66.7% 4/6 • Number of events 23 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Nausea	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	27.3% 3/11 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 16 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	83.3% 5/6 • Number of events 13 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Influenza	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	36.4% 4/11 • Number of events 10 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	45.5% 5/11 • Number of events 11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Myalgia	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	36.4% 4/11 • Number of events 15 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Sinusitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	27.3% 3/11 • Number of events 7 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Upper respiratory tract infection	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	36.4% 4/11 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	66.7% 4/6 • Number of events 17 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	27.3% 3/11 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Muscle strain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	66.7% 4/6 • Number of events 11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	27.3% 3/11 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	36.4% 4/11 • Number of events 6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Rash	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	66.7% 4/6 • Number of events 11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Chills	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 8 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Hypertension	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Migraine	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	66.7% 4/6 • Number of events 13 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Muscular weakness	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	27.3% 3/11 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Bronchitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Dizziness	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	27.3% 3/11 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 9 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Pyrexia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 7 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Vomiting	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 8 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Abdominal distension	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Constipation	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Iron deficiency	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Peripheral swelling	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Skin laceration	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Ear and labyrinth disorders Vertigo	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Blood and lymphatic system disorders Anemia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Burning sensation	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Chest discomfort	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Gastritis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Hemorrhoids	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Head injury	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Hypotension	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Joint injury	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Large intestine polyp	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	27.3% 3/11 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Limb injury	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Lower respiratory tract infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Non-cardiac chest pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Rhinitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Tremor	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Viral infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	50.0% 3/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Acne	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Alkalosis hypochloremic	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 5 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Angina pectoris	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Psychiatric disorders Anxiety	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Blood pressure increased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Body temperature increased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Bone contusion	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Bundle branch block right	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Catheter site bruise	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Catheter site pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Conjunctivitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Cystitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Psychiatric disorders Depression	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Dizziness postural	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Dysarthria	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Dysphagia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Ear and labyrinth disorders Ear discomfort	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Folliculitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Forced expiratory volume decreased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Forced vital capacity decreased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Gamma-glutamyltransferase increased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Renal and urinary disorders Hematuria	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Hordeolum	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Hot flush	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Hypoesthesia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Endocrine disorders Hypothyroidism	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Influenza-like illness	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Infusion site extravasation	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Infusion site pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Infusion site swelling	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Psychiatric disorders Insomnia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Metabolic alkalosis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Muscle fatigue	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 7 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Edema peripheral	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Palpitations	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Pneumonia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Presyncope	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Respiratory tract infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Rib fracture	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations SARS-CoV-2 test positive	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Sciatica	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	18.2% 2/11 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Supraventricular tachycardia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Ear and labyrinth disorders Tinnitus	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Toothache	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	33.3% 2/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Vaccination site pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Ear and labyrinth disorders Vertigo positional	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Psychiatric disorders Abnormal dreams	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Reproductive system and breast disorders Amenorrhea	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Anal fissure	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Arterial occlusive disease	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Asthenia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Atrial fibrillation	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Atrioventricular block first degree	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Endocrine disorders Autoimmune thyroiditis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Balance disorder	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Hepatobiliary disorders Biliary dyskinesia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Renal and urinary disorders Bilirubinuria	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Eye disorders Blepharitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Blister	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Blood glucose decreased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Blood testosterone decreased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Blood uric acid increased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Blood urine present	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations C-reactive protein increased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Renal and urinary disorders Calculus bladder	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Cardiac flutter	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Carpal tunnel syndrome	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Eye disorders Cataract	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Ear and labyrinth disorders Cerumen impaction	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Eye disorders Chalazion	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Chest pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Clubbing	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Cognitive disorder	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Complication associated with device	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Culture wound positive	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Cyanosis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Ear and labyrinth disorders Deafness unilateral	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Deep vein thrombosis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Dehydration	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Eye disorders Diplopia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Immune system disorders Drug hypersensitivity	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Eye disorders Dry eye	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Dry mouth	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Dysstasia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Renal and urinary disorders Dysuria	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Ear infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Ear and labyrinth disorders Ear pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Enteritis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Eosinophil count increased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Eye infection bacterial	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Facial paresis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Feeling abnormal	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Feeling hot	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Feeling jittery	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Fluid overload	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Food poisoning	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Fungal skin infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Gastritis erosive	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Gastroenteritis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Gastroenteritis viral	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders General physical health deterioration	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Eye disorders Glaucoma	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Gout	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Graft infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Hemiplegic migraine	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Hepatobiliary disorders Hepatic cyst	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Herpes zoster	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Endocrine disorders Hyperthyroidism	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Hypokalemia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Inguinal hernia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Psychiatric disorders Initial insomnia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Blood and lymphatic system disorders Iron deficiency anemia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Joint hyperextension	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Joint noise	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Labyrinthitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Lacunar infarction	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Left atrial enlargement	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Lip swelling	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Lipoprotein (a) increased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Medial tibial stress syndrome	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Reproductive system and breast disorders Metrorrhagia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Migraine with aura	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 4 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Mouth ulceration	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Mycobacterium test positive	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Neck mass	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Nodule	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Eye disorders Ocular discomfort	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Oral herpes	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 3 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Oral viral infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Orthostatic hypotension	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Pallor	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papilloma	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Paresthesia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Paronychia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Vascular disorders Peripheral venous disease	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Pharyngitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Post herpetic neuralgia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Prostatic specific antigen increased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Protein urine	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Renal and urinary disorders Proteinuria	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Nervous system disorders Radial nerve palsy	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Regurgitation	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Immune system disorders Seasonal allergy	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Sepsis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Sinus tachycardia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Skin discoloration	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Skin mass	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Skin and subcutaneous tissue disorders Skin edema	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Snake bite	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Soft tissue swelling	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
General disorders Swelling	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Gastrointestinal disorders Swollen tongue	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Tachycardia	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 9 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Endocrine disorders Thyroid mass	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Injury, poisoning and procedural complications Tissue injury	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Tooth abscess	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Tooth infection	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Transaminases increased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Respiratory, thoracic and mediastinal disorders Upper respiratory tract congestion	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Cardiac disorders Ventricular hypertrophy	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Infections and infestations Viral pharyngitis	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Eye disorders Vision blurred	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 2 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations Vitamin D decreased	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	9.1% 1/11 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).
Investigations White blood cells urine positive	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/11 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	16.7% 1/6 • Number of events 1 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).	0.00% 0/6 • Adverse event data collected over duration of the study. Duration of participation varied by patient (range: 1.4 to 93.1 months).

Additional Information

MedInfo

Amicus Therapeutics, Inc.

Phone: 001 609-662-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place