Trial Outcomes & Findings for An Open Label Study of LMI070 (Branaplam) in Type 1 Spinal Muscular Atrophy (SMA) (NCT NCT02268552)

NCT ID: NCT02268552

Last Updated: 2025-04-09

Results Overview

A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant therapies that occurs within the first 14 days of treatment with LMI070 and meets any of the criteria for blood and lymphatic system disorders, gastrointestinal disorders, investigations and other toxicities considered clinically significant.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: Baseline up to 2 weeks for Part 1
• Results posted on: 2025-04-09

Participant Flow

Cohorts in Part 1 were enrolled sequentially following a 14 day dose-limiting toxicity (DLT) window for each cohort before escalating to the next level. Forty participants were enrolled but only 38 received treatment.

Participant milestones

Measure	Part 1 LMI070 6mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 12mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Part 1 STARTED	2	2	2	4	3	0	0
Part 1 COMPLETED	1	1	1	1	3	0	0
Part 1 NOT COMPLETED	1	1	1	3	0	0	0
Part 2 STARTED	0	0	0	0	0	10	15
Part 2 COMPLETED	0	0	0	0	0	10	12
Part 2 NOT COMPLETED	0	0	0	0	0	0	3
Part 3 Extension STARTED	1	1	1	1	3	10	12
Part 3 Extension COMPLETED	0	0	0	0	0	0	0
Part 3 Extension NOT COMPLETED	1	1	1	1	3	10	12

Reasons for withdrawal

Measure	Part 1 LMI070 6mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 12mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Part 1 Death	1	1	1	2	0	0	0
Part 1 Subject/guardian decision	0	0	0	1	0	0	0
Part 2 Death	0	0	0	0	0	0	2
Part 2 Subject/guardian decision	0	0	0	0	0	0	1
Part 3 Extension Death	0	1	1	1	1	1	0
Part 3 Extension Early termination of trial	1	0	0	0	2	9	11
Part 3 Extension Subject/guardian decision	0	0	0	0	0	0	1

Baseline Characteristics

An Open Label Study of LMI070 (Branaplam) in Type 1 Spinal Muscular Atrophy (SMA)

Baseline characteristics by cohort

Measure	Part 1 LMI070 6mg/m2 n=2 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=2 Participants Single weekly dose for 13 weeks via e teral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 24mg/m2 n=2 Participants Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 n=4 Participants Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 n=3 Participants Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg n=10 Participants LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg n=15 Participants LMI070 2.5 mg/kg by enteral route via feeding tube or oral	Total n=38 Participants Total of all reporting groups
Age, Continuous	3.0 months STANDARD_DEVIATION 1.41 • n=5 Participants	4.5 months STANDARD_DEVIATION 0.71 • n=7 Participants	3.5 months STANDARD_DEVIATION 2.12 • n=5 Participants	3.8 months STANDARD_DEVIATION 1.71 • n=4 Participants	5.3 months STANDARD_DEVIATION 2.08 • n=21 Participants	4.38 months STANDARD_DEVIATION 1.521 • n=8 Participants	3.81 months STANDARD_DEVIATION 1.188 • n=8 Participants	4.21 months STANDARD_DEVIATION 1.481 • n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants	9 Participants n=8 Participants	22 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants	6 Participants n=8 Participants	16 Participants n=24 Participants
Race/Ethnicity, Customized Caucasian	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	10 Participants n=8 Participants	14 Participants n=8 Participants	34 Participants n=24 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants

PRIMARY outcome

Timeframe: Baseline up to 2 weeks for Part 1

Population: Safety analysis set. No DLTs were observed, therefore maximum tolerated dose could not be determined.

A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant therapies that occurs within the first 14 days of treatment with LMI070 and meets any of the criteria for blood and lymphatic system disorders, gastrointestinal disorders, investigations and other toxicities considered clinically significant.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=2 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=2 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 n=2 Participants Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 n=4 Participants Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 n=3 Participants Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Number of Participants With Dose Limiting Toxicities (DLT) in Part 1 - Safety Analysis Set (SAS)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Baseline up to approximately 83 months

Population: Safety analysis set, all enrolled participants who received at least one dose of study drug.

TEAEs are defined as adverse events starting on or after the first dose of study treatment that were absent pre-treatment, or events present prior to the first dose but increased in severity after the first dose. Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=2 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=2 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 n=2 Participants Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 n=4 Participants Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 n=3 Participants Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg n=10 Participants LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg n=15 Participants LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events and Deaths- SAS Participants with adverse events	2 Participants	2 Participants	2 Participants	4 Participants	3 Participants	10 Participants	15 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events and Deaths- SAS Participants with serious adverse events	2 Participants	2 Participants	2 Participants	4 Participants	3 Participants	8 Participants	11 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events and Deaths- SAS Deaths	1 Participants	2 Participants	2 Participants	3 Participants	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: from 0 h to 168 h after first/single dose

Population: Pharmacokinetic analysis set

The area under the plasma (or serum or blood) concentration-time curve from time zero to infinity [mass x time / volume]

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=12 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUCinf) After a Single Dose - Part 1 - Pharmacokinetics Analysis Set (PAS) 0.321 mg/kg - Actual	378 h*ng/mL Standard Deviation 31.9	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUCinf) After a Single Dose - Part 1 - Pharmacokinetics Analysis Set (PAS) 0.654 mg/kg - Actual	892 h*ng/mL Standard Deviation 12.3	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUCinf) After a Single Dose - Part 1 - Pharmacokinetics Analysis Set (PAS) 1.39 mg/kg - Actual	1820 h*ng/mL	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUCinf) After a Single Dose - Part 1 - Pharmacokinetics Analysis Set (PAS) 2.49 mg/kg - Actual	3310 h*ng/mL Standard Deviation 1340	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUCinf) After a Single Dose - Part 1 - Pharmacokinetics Analysis Set (PAS) 2.94 mg/kg - Actual	3800 h*ng/mL Standard Deviation 1590	—	—	—	—	—	—

SECONDARY outcome

Timeframe: from 0 h to 168 h after first/single dose

Population: Pharmacokinetic analysis set

The area under the plasma (or serum or blood) concentration-time curve from time zero to infinity [mass x time / volume] for all observations. AUC values used for comparison are combined from AUCinf values after single dose and AUC 0-168h values after repeated administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=63 observations by subject and time point Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUCinf) for All Observation Periods - Part 1 - PAS 0.299 mg/kg - Actual	413 h*ng/mL Standard Deviation 98.3	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUCinf) for All Observation Periods - Part 1 - PAS 0.644 mg/kg - Actual	761 h*ng/mL Standard Deviation 170	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUCinf) for All Observation Periods - Part 1 - PAS 1.30 mg/kg - Actual	1340 h*ng/mL Standard Deviation 381	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUCinf) for All Observation Periods - Part 1 - PAS 2.52 mg/kg - Actual	3310 h*ng/mL Standard Deviation 850	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUCinf) for All Observation Periods - Part 1 - PAS 2.95 mg/kg - Actual	4210 h*ng/mL Standard Deviation 1030	—	—	—	—	—	—

SECONDARY outcome

Timeframe: from 0 h to 168 h after first/single dose

Population: Pharmacokinetic analysis set

The observed maximum plasma concentration following drug administration [mass / volume).

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=12 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax After a Single Dose - Part 1 - PAS 0.321 mg/kg - Actual	9.10 ng/mL Standard Deviation 1.22	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax After a Single Dose - Part 1 - PAS 0.654 mg/kg - Actual	18.6 ng/mL Standard Deviation 1.63	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax After a Single Dose - Part 1 - PAS 1.39 mg/kg - Actual	55.6 ng/mL	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax After a Single Dose - Part 1 - PAS 2.49 mg/kg - Actual	53.2 ng/mL Standard Deviation 9.50	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax After a Single Dose - Part 1 - PAS 2.94 mg/kg - Actual	72.4 ng/mL Standard Deviation 16.7	—	—	—	—	—	—

SECONDARY outcome

Timeframe: from 0 h to 168 h after first/single dose

Population: Pharmacokinetic analysis set

The observed maximum plasma (or serum or blood) concentration following drug administration [mass / volume

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=89 observations by subject and time point Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax for All Observation Periods - Part 1 - PAS 0.299 mg/kg - Actual	8.84 ng/mL Standard Deviation 3.58	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax for All Observation Periods - Part 1 - PAS 0.644 mg/kg - Actual	15.3 ng/mL Standard Deviation 4.10	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax for All Observation Periods - Part 1 - PAS 1.30 mg/kg - Actual	37.8 ng/mL Standard Deviation 12.8	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax for All Observation Periods - Part 1 - PAS 2.51 mg/kg - Actual	69.1 ng/mL Standard Deviation 15.7	—	—	—	—	—	—
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax for All Observation Periods - Part 1 - PAS 2.95 mg/kg - Actual	96.5 ng/mL Standard Deviation 32.7	—	—	—	—	—	—

SECONDARY outcome

Timeframe: from 0 h to 168 h after first/single dose

Population: Pharmacokinetic analysis set

The area under the plasma (or serum or blood) concentration-time curve from time zero to infinity [mass x time / volume)

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=10 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=15 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUC) After a Single Dose - Part 2 - PAS	1150 h*ng/mL Standard Deviation 357	4060 h*ng/mL Standard Deviation 734	—	—	—	—	—

SECONDARY outcome

Timeframe: from 0 h to 168 h after first/single dose

Population: Pharmacokinetic analysis set

The area under the plasma (or serum or blood) concentration-time curve from time zero to infinity [mass x time / volume). AUC values used for comparison are combined from AUCinf values after single dose and AUC0-168h values after repeated administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=28 observations by subject and time point Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=29 observations by subject and time point Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Summary of Plasma Pharmacokinetic (PK) Parameter Area Under the Curve (AUC) for All Observation Periods - Part 2 - PAS	1020 h*ng/mL Standard Deviation 278	3470 h*ng/mL Standard Deviation 909	—	—	—	—	—

SECONDARY outcome

Timeframe: from 0 h to 168 h after first/single dose

Population: Pharmacokinetic analysis set

The observed maximum plasma (or serum or blood) concentration following drug administration [mass / volume)

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=10 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=15 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax for a Single Dose - Part 2 - PAS	22.0 ng/mL Standard Deviation 5.70	82.0 ng/mL Standard Deviation 22.5	—	—	—	—	—

SECONDARY outcome

Timeframe: from 0 h to 168 h after first/single dose

Population: Pharmacokinetic analysis set

The observed maximum plasma (or serum or blood) concentration following drug administration [mass / volume)

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=29 observations by subject and time point Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=38 observations by subject and time point Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Summary of Plasma Pharmacokinetic (PK) Parameter Cmax for All Observation Periods - Part 2 - PAS	21.7 ng/mL Standard Deviation 5.71	77.4 ng/mL Standard Deviation 27.5	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52 and Month 6 of Part 3

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

The effect of branaplam on growth parameters: Length (measured from the top of the head to the sole of the foot), Head circumference and Chest circumference (measured across nipple line). Mean change from baseline in cm is presented

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=13 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=25 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Change From Baseline in Growth Parameters: Chest Circumference, Head Circumference and Body Length - Full Analysis Set (FAS) Chest - Week 52	4.68 cm Standard Deviation 2.4769	5.656 cm Standard Deviation 3.0167	—	—	—	—	—
Change From Baseline in Growth Parameters: Chest Circumference, Head Circumference and Body Length - Full Analysis Set (FAS) Chest - P3 Month 6	14.750 cm Standard Deviation 0548	8.582 cm Standard Deviation 2.7423	—	—	—	—	—
Change From Baseline in Growth Parameters: Chest Circumference, Head Circumference and Body Length - Full Analysis Set (FAS) Head -Week 52	5.030 cm Standard Deviation 1.1235	5.111 cm Standard Deviation 1.3407	—	—	—	—	—
Change From Baseline in Growth Parameters: Chest Circumference, Head Circumference and Body Length - Full Analysis Set (FAS) Head -P3 Month 6	9.717 cm Standard Deviation 1.8766	6.359 cm Standard Deviation 1.2971	—	—	—	—	—
Change From Baseline in Growth Parameters: Chest Circumference, Head Circumference and Body Length - Full Analysis Set (FAS) Length - Week 52	16.950 cm Standard Deviation 3.7825	16.942 cm Standard Deviation 4.5806	—	—	—	—	—
Change From Baseline in Growth Parameters: Chest Circumference, Head Circumference and Body Length - Full Analysis Set (FAS) Length - P3 Month 6	52.140 cm Standard Deviation 9.8766	22.944 cm Standard Deviation 3.7686	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52 and Month 6 of Part 3

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

The effect of Branaplam on body weight in Kg was measured using a weight scale. Mean change from baseline in Kg is presented

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=13 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=25 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Change From Baseline in Growth Parameter: Body Weight - FAS Week 52	2.739 kg Standard Deviation 1.3545	3.145 kg Standard Deviation 1.5089	—	—	—	—	—
Change From Baseline in Growth Parameter: Body Weight - FAS P3 Month 6	9.546 kg Standard Deviation 3.5069	4.402 kg Standard Deviation 1.3250	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52 and Month 6 of Part 3

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

The effect of branaplam on pulse oximetry in percentage of oxygen saturation was evaluated using a probe that measures oxygen in the blood. Mean change from baseline in percentage of oxygen saturation is reported. Negative numbers indicate a decrease from baseline

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=13 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=25 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Change From Baseline in Respiratory Function: Pulse Oximetry - FAS Week 52	-0.8 percentage Standard Deviation 2.59	-0.1 percentage Standard Deviation 1.56	—	—	—	—	—
Change From Baseline in Respiratory Function: Pulse Oximetry - FAS P3 Month 6	-0.7 percentage Standard Deviation 2.58	0.0 percentage Standard Deviation 1.83	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52 and Month 6 of Part 3

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

The effect of branaplam on respiratory rate was evaluated by counting the number of breaths for one minute. Mean change from baseline in breaths per minute is reported"

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=12 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=25 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Change From Baseline in Respiratory Function: Respiratory Rate - FAS Week 52	41.3 breaths per minute Standard Deviation 7.57	40.5 breaths per minute Standard Deviation 13.46	—	—	—	—	—
Change From Baseline in Respiratory Function: Respiratory Rate - FAS P3 Month 6	29.2 breaths per minute Standard Deviation 6.59	37.2 breaths per minute Standard Deviation 8.95	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52 and Month 6 of Part 3

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

A paradoxical breathing occurs when one compartment moves out of phase compared to another one.

In SMA type I, paradoxical breathing is often a sign of breathing problems where the pulmonary ribcage moves inward during inspiration rather than outward while the abdomen expands.

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=13 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=25 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Number of Participants With Presence of Paradoxical Breathing - FAS Week 52	5 Participants	15 Participants	—	—	—	—	—
Number of Participants With Presence of Paradoxical Breathing - FAS P3 Month 6	4 Participants	14 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52 and Month 6 of Part 3

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

The effect of branaplam on respiratory status was evaluated by measuring the circumference of the ribcage while taking a breathe in and out while quiet or sleeping.

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=18 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Change From Baseline in Respiratory Function: Chest Circumference During Quiet Breathing - End of Inspiration and Expiration - FAS Week 52 - end of inspiration	—	5.964 cm Standard Deviation 3.6345	—	—	—	—	—
Change From Baseline in Respiratory Function: Chest Circumference During Quiet Breathing - End of Inspiration and Expiration - FAS P3 Month 6 - end of inspiration	—	8.535 cm Standard Deviation 3.3083	—	—	—	—	—
Change From Baseline in Respiratory Function: Chest Circumference During Quiet Breathing - End of Inspiration and Expiration - FAS Week 52 - end of expiration	—	6.033 cm Standard Deviation 3.9466	—	—	—	—	—
Change From Baseline in Respiratory Function: Chest Circumference During Quiet Breathing - End of Inspiration and Expiration - FAS P3 Month 6 - end of expiration	—	9.147 cm Standard Deviation 3.5755	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52 and Month 6 of Part 3

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

CHOP INTEND is a motor test measure for SMA Type 1 and similarly weak infants with neuromuscular disease. The CHOP INTEND provides a useful measure of motor skills and strength in this population. It is a 16 item, 64 point scale. Each item (motor skill) is given a score from zero to 4: zero indicates can't complete the movement, 1 to 3 indicates partial performance and a 4 indicates person can complete the movement on their own without assistance. These scores are added up to a possible total score of 64 and higher scores indicate better outcomes.

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=8 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=18 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Summary of CHOP INTEND Total Score - Parts 1 and 3 and Parts 2 and 3 - FAS Week 52	38.1 scores on a scale Standard Deviation 8.69	43.6 scores on a scale Standard Deviation 6.79	—	—	—	—	—
Summary of CHOP INTEND Total Score - Parts 1 and 3 and Parts 2 and 3 - FAS Part 3, Month 6	26.0 scores on a scale	44.7 scores on a scale Standard Deviation 8.73	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up Week 78

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

To evaluate the efficacy of branaplam on preservation of oral feeding

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=13 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=25 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Number of Participants Fed Orally or by Feeding Tube for Parts 1 and 3 and Parts 2 and 3 - FAS Only exclusively orally fed	3 participants	18 participants	—	—	—	—	—
Number of Participants Fed Orally or by Feeding Tube for Parts 1 and 3 and Parts 2 and 3 - FAS Only exclusively tube fed	0 participants	0 participants	—	—	—	—	—
Number of Participants Fed Orally or by Feeding Tube for Parts 1 and 3 and Parts 2 and 3 - FAS Started on orally fed, switched to tube fed	0 participants	2 participants	—	—	—	—	—
Number of Participants Fed Orally or by Feeding Tube for Parts 1 and 3 and Parts 2 and 3 - FAS Started on tube fed, switched to orally fed	0 participants	0 participants	—	—	—	—	—
Number of Participants Fed Orally or by Feeding Tube for Parts 1 and 3 and Parts 2 and 3 - FAS Other (mixture of both tube and oral feeding)	8 participants	5 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 52 and Month 6 of Part 3

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

HINE Section 2 is a standardized evaluation of motor function. It evaluates 8 items; grasp, head control, kicking, rolling over, sitting up, crawling, standing and walking. Motor skills are assigned a score of 0 to 3 to 5 points and zero means the child lacks that motor skill. The maximum score is 26 which is dependent on age, level of development and severity of disease. A higher score is a better outcome. This assessment was added with amendment 6, therefore no baseline was available.

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=13 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=25 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Number of Participants and HINE Motor Subscale Milestones (Ability to Sit, Stand or Walk Without Support) - FAS Week 52 Sitting - Stable independent sit or Pivots (rotates)	1 participants	1 participants	—	—	—	—	—
Number of Participants and HINE Motor Subscale Milestones (Ability to Sit, Stand or Walk Without Support) - FAS Week 52 Standing - Supports weight	0 participants	2 participants	—	—	—	—	—
Number of Participants and HINE Motor Subscale Milestones (Ability to Sit, Stand or Walk Without Support) - FAS Week 52: Walking - Makes any attempt (i.e., bounces)	0 participants	1 participants	—	—	—	—	—
Number of Participants and HINE Motor Subscale Milestones (Ability to Sit, Stand or Walk Without Support) - FAS Part 3, Month 6: Sitting - Stable independent sit or Pivots (rotates)	0 participants	4 participants	—	—	—	—	—
Number of Participants and HINE Motor Subscale Milestones (Ability to Sit, Stand or Walk Without Support) - FAS Part 3, Month 6: Standing - Supports weight	0 participants	5 participants	—	—	—	—	—
Number of Participants and HINE Motor Subscale Milestones (Ability to Sit, Stand or Walk Without Support) - FAS Part 3, Month 6: Walking - Makes any attempt (i.e., bounces)	0 participants	2 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 52 and Month 6 of Part 3

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

HINE Section 2 is a standardized evaluation of motor function. It evaluates 8 items; grasp, head control, kicking, rolling over, sitting up, crawling, standing and walking. Motor skills are assigned a score of 0 to 3 to 5 points and zero means the child lacks that motor skill. The maximum score is 26 which is dependent on age, level of development and severity of disease. A higher score is a better outcome. This assessment was added with amendment 6, therefore no baseline was available.

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=5 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=25 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Summary of Hammersmith Infant Neurologic Examination Section 2 (HINE-2) - FAS Week 52	3.3 total scores Standard Deviation 2.31	4.9 total scores Standard Deviation 3.44	—	—	—	—	—
Summary of Hammersmith Infant Neurologic Examination Section 2 (HINE-2) - FAS Part 3 Month 6	3.0 total scores Standard Deviation 2.12	7.7 total scores Standard Deviation 4.82	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to 82 months

Population: Full analysis set - Number of patients who have an assessment available at Baseline and the relevant post-baseline visit.

BiBAP (bilevel positive airway pressure) ventilation is a 2 level breathing support which has a tube that connects to a mask. It provides a different level of air pressure for inhalation vs. exhalation, whereas a CPAP (continuous positive airway pressure) only pumps one level of air pressure but is also non-invasiive. Invasive ventilation is delivered via an endotracheal or tracheostomy tube.

In alignment with the study objectives and protocol defined analyses, secondary efficacy endpoints were analyzed according to the treatment group that participants were assigned at baseline (Part 1&3 and Part 2&3) irrespective of study dose or route of administration.

Outcome measures

Measure	Part 1 LMI070 6mg/m2 n=11 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 12mg/m2 n=25 Participants Enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes for 13 weeks	Part 1 LMI070 24mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Ventilation Use for Parts 1 and 3 and Parts 2 and 3 - FAS Non-invasive ventilation - BiPAP	9 participants	18 participants	—	—	—	—	—
Ventilation Use for Parts 1 and 3 and Parts 2 and 3 - FAS Non-invasive ventilation - CPAP	3 participants	2 participants	—	—	—	—	—
Ventilation Use for Parts 1 and 3 and Parts 2 and 3 - FAS Invasive ventilation	4 participants	5 participants	—	—	—	—	—

Adverse Events

Part 1 LMI070 6mg/m2

Serious events: 2 serious events

Other events: 2 other events

Deaths: 1 deaths

Part 1 LMI070 12mg/m2

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Part 1 LMI070 24mg/m2

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Part 1 LMI070 48mg/m2

Serious events: 4 serious events

Other events: 4 other events

Deaths: 3 deaths

Part 1 LMI070 60mg/m2

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Part 2 LMI070 0.625 mg/kg

Serious events: 8 serious events

Other events: 10 other events

Deaths: 1 deaths

Part 2 LMI070 2.5 mg/kg

Serious events: 11 serious events

Other events: 15 other events

Deaths: 2 deaths

Serious adverse events

Measure	Part 1 LMI070 6mg/m2 n=2 participants at risk Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 12mg/m2 n=2 participants at risk Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 24mg/m2 n=2 participants at risk Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 n=4 participants at risk Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 n=3 participants at risk Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg n=10 participants at risk LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg n=15 participants at risk LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Apnoea	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Bronchostenosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Vascular disorders Circulatory collapse	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Vascular disorders Hypertension	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Pericardial effusion	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Arrhythmia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Bradycardia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Cardiac arrest	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Supraventricular tachycardia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Tachycardia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Constipation	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Gastric ulcer	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Multiple organ dysfunction syndrome	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Pyrexia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Hepatobiliary disorders Hepatomegaly	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Immune system disorders Hypersensitivity	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Bronchiolitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Bronchitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Bronchitis bacterial	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations COVID-19 pneumonia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Cellulitis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Diarrhoea infectious	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Enterovirus infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Gastroenteritis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Nasopharyngitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Otitis media	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Parainfluenzae virus infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Pneumococcal sepsis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Pneumonia	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	40.0% 4/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	46.7% 7/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Pneumonia aspiration	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Pneumonia bacterial	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Pseudomonas infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Pyelonephritis acute	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Respiratory tract infection	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Respiratory tract infection viral	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Rhinovirus infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Sepsis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Septic shock	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Staphylococcal sepsis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Urinary tract infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Shunt malfunction	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Ejection fraction decreased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations N-terminal prohormone brain natriuretic peptide increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Oxygen saturation decreased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Respiratory syncytial virus test positive	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Rotavirus test positive	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Salmonella test positive	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Transaminases increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Ultrasound kidney abnormal	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Hypophagia	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Malnutrition	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Epilepsy	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Hydrocephalus	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Hypercalciuria	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Renal tubular disorder	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.

Other adverse events

Measure	Part 1 LMI070 6mg/m2 n=2 participants at risk Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 12mg/m2 n=2 participants at risk Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 24mg/m2 n=2 participants at risk Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 48mg/m2 n=4 participants at risk Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 1 LMI070 60mg/m2 n=3 participants at risk Single weekly dose for 13 weeks via enteral dosing using nasogastric or nasojejunal or percutaneous endoscopic gastrostomy feeding tubes	Part 2 LMI070 0.625 mg/kg n=10 participants at risk LMI070 0.625 mg/kg by enteral route via feeding tube or oral	Part 2 LMI070 2.5 mg/kg n=15 participants at risk LMI070 2.5 mg/kg by enteral route via feeding tube or oral
Infections and infestations Gastroenteritis viral	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Gastrointestinal infection	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Hordeolum	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Infected bite	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Klebsiella infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Medical device site infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Nasopharyngitis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	40.0% 6/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Oral candidiasis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Oral fungal infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Otitis externa	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Otitis media	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Otitis media acute	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Pharyngitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Pneumonia	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Pseudomonas infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Pyuria	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Rash pustular	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Respiratory tract infection	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	30.0% 3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Respiratory tract infection viral	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Rhinitis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 3/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	26.7% 4/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Rhinovirus infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Roseola	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Skin bacterial infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Skin infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Staphylococcal infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Tonsillitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Upper respiratory tract infection	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 3/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	40.0% 4/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Urethritis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Urinary tract infection	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 3/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Varicella	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Viral infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Flatulence	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Vulvitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Arthropod bite	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Exposure to SARS-CoV-2	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Humerus fracture	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Joint dislocation	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Hiatus hernia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Sunburn	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Tracheostomy malfunction	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Alanine aminotransferase increased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 5/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Leukopenia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Monocytosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Neutropenia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	30.0% 3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Polycythaemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Reticulocytopenia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Sinus bradycardia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Sinus node dysfunction	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	40.0% 4/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Blood and lymphatic system disorders White blood cell disorder	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Arrhythmia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Atrial tachycardia	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Bradycardia	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Cardiac failure	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Myocarditis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Pericardial effusion	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Right ventricular hypertrophy	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Supraventricular tachycardia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Cardiac disorders Tachycardia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Congenital, familial and genetic disorders Cryptorchism	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Congenital, familial and genetic disorders Dacryostenosis congenital	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Congenital, familial and genetic disorders Developmental hip dysplasia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Congenital, familial and genetic disorders Phimosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Congenital, familial and genetic disorders Plagiocephaly	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Ear and labyrinth disorders Ear pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Ear and labyrinth disorders Tympanic membrane hyperaemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Endocrine disorders Hyperthyroidism	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Eye disorders Astigmatism	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Eye disorders Blepharitis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Eye disorders Chalazion	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Eye disorders Heterophoria	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Eye disorders Hypermetropia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Eye disorders Myopia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Eye disorders Ocular hyperaemia	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Eye disorders Optic atrophy	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Eye disorders Strabismus	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Abdominal pain upper	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Anal fissure	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Constipation	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	70.0% 7/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Dental cyst	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Diarrhoea	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 3/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Dysphagia	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Faecaloma	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Food poisoning	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Functional gastrointestinal disorder	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood alkaline phosphatase decreased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Gingival pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Gingival swelling	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 3/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	30.0% 3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	26.7% 4/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Haematochezia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Inguinal hernia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Malocclusion	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Nausea	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Oesophagitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Oesophagitis haemorrhagic	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations C-reactive protein increased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Regurgitation	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Malaise	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Teething	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Tongue disorder	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Asthenia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Body temperature increased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Toothache	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Gastrointestinal disorders Vomiting	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 3/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Catheter site haemorrhage	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Discomfort	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Fatigue	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Granuloma	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Hyperpyrexia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Hyperthermia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	26.7% 4/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Medical device site granuloma	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Medical device pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Non-cardiac chest pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
General disorders Pyrexia	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 3/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	70.0% 7/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	40.0% 6/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Gamma-glutamyltransferase increased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Hepatobiliary disorders Hepatomegaly	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Immune system disorders Allergy to arthropod bite	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Immune system disorders Drug hypersensitivity	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Immune system disorders Immunisation reaction	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Immune system disorders Multiple allergies	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Asymptomatic COVID-19	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Bacterial disease carrier	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Cytomegalovirus infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Bacterial rhinitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Bronchitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 5/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	53.3% 8/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Bronchitis bacterial	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations COVID-19	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Candida infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Cellulitis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Conjunctivitis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Gastroenteritis norovirus	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Cystitis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Dermatitis infected	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Ear infection	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Ear infection viral	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Eye infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Folliculitis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Fungal skin infection	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Infections and infestations Gastroenteritis	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Aspartate aminotransferase increased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 5/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood albumin decreased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood creatine phosphokinase increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood creatinine decreased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	30.0% 3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood iron decreased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood lactate dehydrogenase increased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood parathyroid hormone decreased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood potassium decreased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Blood potassium increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Brain natriuretic peptide increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Crystal urine present	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Electrocardiogram P pulmonale	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Fungal test positive	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Haematocrit decreased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Haemoglobin decreased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Heart rate decreased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Heart rate increased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations N-terminal prohormone brain natriuretic peptide increased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Nerve conduction studies abnormal	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Neutrophil count decreased	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Oxygen saturation decreased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Platelet count increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Red blood cell count decreased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Reticulocyte count decreased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Transaminases increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Troponin T increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Troponin increased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Ultrasound kidney abnormal	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Urine phosphorus increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Urine uric acid increased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Vitamin D decreased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations Weight decreased	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations White blood cell count decreased	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Investigations White blood cells urine positive	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Decreased appetite	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Feeding disorder	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Feeding intolerance	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Fluid intake reduced	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Hypophagia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Metabolism and nutrition disorders Malnutrition	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Deformity thorax	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Foot deformity	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Fracture pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Joint contracture	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Muscular weakness	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Rib deformity	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Headache	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Musculoskeletal and connective tissue disorders Scoliosis	100.0% 2/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	40.0% 4/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Brain injury	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Cerebral atrophy	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Complex regional pain syndrome	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Facial paresis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Glossopharyngeal nerve disorder	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Hydrocephalus	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Nervous system disorders Motor dysfunction	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Psychiatric disorders Agitation	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Psychiatric disorders Anxiety	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Psychiatric disorders Behaviour disorder	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Psychiatric disorders Irritability	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Psychiatric disorders Restlessness	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Calculus urinary	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Dysuria	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Hypercalciuria	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Ketonuria	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	30.0% 3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Leukocyturia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Nephrocalcinosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Nephrolithiasis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Nephroptosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Proteinuria	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Pyelocaliectasis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Renal and urinary disorders Urinary retention	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Reproductive system and breast disorders Genital rash	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Reproductive system and breast disorders Vulvovaginal dryness	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Reproductive system and breast disorders Vulvovaginal rash	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	13.3% 2/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	100.0% 3/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 2/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Respiratory depression	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Respiratory tract inflammation	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Sputum discoloured	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Respiratory, thoracic and mediastinal disorders Vasomotor rhinitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Blister	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Eczema	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Keratosis pilaris	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Papule	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Perioral dermatitis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 3/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	50.0% 1/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	66.7% 2/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	20.0% 2/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Surgical and medical procedures Therapy cessation	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Surgical and medical procedures Tracheostomy	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	10.0% 1/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Vascular disorders Cyanosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Vascular disorders Diastolic hypertension	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	33.3% 1/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Vascular disorders Hypertension	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	30.0% 3/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Vascular disorders Hypotension	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	6.7% 1/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.
Vascular disorders Thrombosis	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/2 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	25.0% 1/4 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/3 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/10 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.	0.00% 0/15 • Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post last treatment up a maximum of 83 months.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: Novartis.email@Novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial
• Publication restrictions are in place

Restriction type: OTHER