Trial Outcomes & Findings for A Phase I Dose Escalation Study of GSK2879552 in Subjects With Acute Myeloid Leukemia (AML) (NCT NCT02177812)

NCT ID: NCT02177812

Last Updated: 2019-06-28

Results Overview

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function.

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 41 participants
• Primary outcome timeframe: Median of 4 weeks of drug exposure
• Results posted on: 2019-06-28

Participant Flow

A total of 41 participants with relapsed/refractory acute myeloid leukemia (AML) were enrolled in Part 1 at different centers in Australia, Canada and United States. This study was planned to be conducted in 2 parts :Part 1 (dose escalation) and Part 2 (Expansion Cohort).

This study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study and therefore, Part 2 was not conducted. There were no active participants on study when the study was terminated.

Participant milestones

Measure	Part 1:GSK2879552 1mg QD Participants received GSK2879552 1 milligram (mg) orally once daily (QD) in fasted condition with approximately 200 milliliter (mL) of water	Part 1: GSK2879552 2mg QD Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water	Part 1: GSK2879552 4mg QD Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water	Part 1: GSK2879552 12mg QD Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with All-Trans Retinoic Acid (ATRA) at a dose of 45 mg per meter square per day (mg/m\^2/day).	Part 1: GSK2879552 20mg QD PK/PD Expansion Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in Pharmacokinetic/Pharmacodynamics (PK/PD) Expansion cohort to collect adequate data on safety, PK or PD.	Part 2: Expansion Cohort In Part 2, participants were planned to receive the recommended Phase 2 dose of GSK2879552 orally once daily in fasted condition with approximately 200 mL of water alone or in combination with ATRA
Part 1 (Median of 4 Weeks) STARTED	1	2	7	5	6	4	10	6	0
Part 1 (Median of 4 Weeks) COMPLETED	1	2	7	4	5	1	1	4	0
Part 1 (Median of 4 Weeks) NOT COMPLETED	0	0	0	1	1	3	9	2	0
Part 2 (Up to 14 Months) STARTED	0	0	0	0	0	0	0	0	0
Part 2 (Up to 14 Months) COMPLETED	0	0	0	0	0	0	0	0	0
Part 2 (Up to 14 Months) NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Measure	Part 1:GSK2879552 1mg QD Participants received GSK2879552 1 milligram (mg) orally once daily (QD) in fasted condition with approximately 200 milliliter (mL) of water	Part 1: GSK2879552 2mg QD Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water	Part 1: GSK2879552 4mg QD Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water	Part 1: GSK2879552 12mg QD Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with All-Trans Retinoic Acid (ATRA) at a dose of 45 mg per meter square per day (mg/m\^2/day).	Part 1: GSK2879552 20mg QD PK/PD Expansion Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in Pharmacokinetic/Pharmacodynamics (PK/PD) Expansion cohort to collect adequate data on safety, PK or PD.	Part 2: Expansion Cohort In Part 2, participants were planned to receive the recommended Phase 2 dose of GSK2879552 orally once daily in fasted condition with approximately 200 mL of water alone or in combination with ATRA
Part 1 (Median of 4 Weeks) Withdrawal by Subject	0	0	0	0	0	1	2	1	0
Part 1 (Median of 4 Weeks) Physician Decision	0	0	0	0	0	1	1	0	0
Part 1 (Median of 4 Weeks) Adverse Event	0	0	0	1	1	1	6	1	0

Baseline Characteristics

A Phase I Dose Escalation Study of GSK2879552 in Subjects With Acute Myeloid Leukemia (AML)

Baseline characteristics by cohort

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.	Part 2: Expansion Cohort In Part 2, participants were planned to receive the recommended Phase 2 dose of GSK2879552 orally once daily in fasted condition with approximately 200 mL of water alone or in combination with ATRA.	Total n=41 Participants Total of all reporting groups
Age, Continuous	68.0 Years STANDARD_DEVIATION NA • n=5 Participants	73.5 Years STANDARD_DEVIATION 2.12 • n=7 Participants	64.3 Years STANDARD_DEVIATION 5.77 • n=5 Participants	61.0 Years STANDARD_DEVIATION 13.96 • n=4 Participants	71.7 Years STANDARD_DEVIATION 4.08 • n=21 Participants	71.8 Years STANDARD_DEVIATION 4.03 • n=10 Participants	63.1 Years STANDARD_DEVIATION 20.14 • n=115 Participants	65.5 Years STANDARD_DEVIATION 19.07 • n=6 Participants	—	66.1 Years STANDARD_DEVIATION 13.47 • n=64 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	13 Participants n=64 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	7 Participants n=115 Participants	5 Participants n=6 Participants	0 Participants n=6 Participants	28 Participants n=64 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	3 Participants n=64 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=64 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	4 Participants n=64 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=64 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	6 Participants n=115 Participants	4 Participants n=6 Participants	0 Participants n=6 Participants	24 Participants n=64 Participants
Race/Ethnicity, Customized Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	6 Participants n=64 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population comprised of all participants who received at least one dose of study treatment.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) All AEs	1 Participants	2 Participants	7 Participants	5 Participants	6 Participants	4 Participants	10 Participants	6 Participants
Part 1: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) All SAEs	1 Participants	2 Participants	7 Participants	5 Participants	6 Participants	3 Participants	8 Participants	5 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population

An event was considered a DLT if it occursed within the first 28 days of treatment, and meets one of the following criteria unless it can be clearly established that the event was unrelated to treatment: hematologic DLT included myelosuppression, Grade >=3 non-hematologic toxicity that is considered clinically significant and lasts >72 hours, Grade 2 toxicity that in the judgment of the investigator and GSK Medical Monitor is dose-limiting and treatment delay of >=42 days due to unresolved toxicity.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Number of Participants With Dose Limiting Toxicities (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population

The number of participants who had any dose reduction or delay have been presented.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Number of Participants With AE Leading to Dose Reductions or Delays AEs leading to dose reduction	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Part 1: Number of Participants With AE Leading to Dose Reductions or Delays AEs leading to dose interruption/delay	0 Participants	0 Participants	2 Participants	3 Participants	5 Participants	0 Participants	6 Participants	1 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population

Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Number of Participants With Withdrawals Due to Toxicities	0 Participants	0 Participants	0 Participants	1 Participants	4 Participants	2 Participants	4 Participants	2 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to assess clinical chemistry parameters like urea/blood urea nitrogen (BUN), calcium, potassium, aspartate aminotransferase (AST), total bilirubin, direct bilirubin, creatinine, chloride, alanine aminotransferase (ALT), uric acid, glucose, total carbon dioxide (CO2), gamma glutamyl transferase (GGT), albumin, sodium, alkaline phosphatase, total protein, phosphate, lactate dehydrogenase (LDH). Laboratory values were as per local labs per site with own normal ranges. Values above range were reported as high and values below range as low. Data for worst case post Baseline is reported.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Chloride,to Low,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Chloride,to High,n=1,2,7,5,6,4,10,6	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range CO2/Bicarbonate,to High,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Lactate Dehydrogenase,to Low,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	2 Participants	2 Participants	2 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Total Protein,to High,n=1,2,7,4,6,4,10,6	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Urea/BUN,to Low,n=1,2,7,5,6,4,10,6	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Direct Bilirubin,to Low,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Direct Bilirubin,to High,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	5 Participants	3 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range CO2/Bicarbonate,to Low,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	0 Participants	2 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Lactate Dehydrogenase,to High,n=1,2,7,5,6,4,10,6	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	3 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Total Protein,to Low,n=1,2,7,4,6,4,10,6	0 Participants	1 Participants	3 Participants	2 Participants	4 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range Urea/BUN,to High,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	3 Participants	1 Participants	2 Participants	0 Participants	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for analysis of clinical chemistry parameters based on common terminology criteria for adverse events (CTCAE) version 4.0, where Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life threatening consequences. Data for any increase in grade of worst-case on-therapy has been provided.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Albumin, n=1,2,7,5,6,4,10,6	1 Participants	2 Participants	5 Participants	3 Participants	4 Participants	4 Participants	6 Participants	3 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline ALP, n=1,2,7,5,6,4, 10, 6	0 Participants	0 Participants	3 Participants	2 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline AST, n=1,2,7,5,6,4,10,6	1 Participants	2 Participants	3 Participants	2 Participants	1 Participants	1 Participants	3 Participants	1 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Total bilirubin, n=1,2,7,5,6,4,10,6	1 Participants	1 Participants	2 Participants	1 Participants	3 Participants	0 Participants	4 Participants	2 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Hypoglycemia,n= 1,2,7,5,6,4,10,6	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline GGT,n=1,2,7,5,3,1,8,3	0 Participants	0 Participants	5 Participants	4 Participants	2 Participants	0 Participants	5 Participants	2 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Hyperkalemia,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Hypernatremia, n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Phosphorus, n=1,2,7,5,6,4,10,6	1 Participants	1 Participants	6 Participants	2 Participants	5 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline ALT, n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	4 Participants	3 Participants	1 Participants	1 Participants	5 Participants	2 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Hypercalcemia, n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Creatinine,n=1,2,7,5,6,4,10,6	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	4 Participants	1 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Hyperglycemia,n= 0,1,7,5,6,4,9,6	0 Participants	0 Participants	4 Participants	2 Participants	1 Participants	0 Participants	4 Participants	4 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Hypoglycemia,n=0,1,7,5,6,4,9,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Hypokalemia,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	3 Participants	4 Participants	3 Participants	2 Participants	6 Participants	0 Participants
Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline Hyponatremia, n=1,2,7,5,6,4,10,6	1 Participants	1 Participants	2 Participants	0 Participants	5 Participants	1 Participants	5 Participants	3 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected to assess hematology parameters like mean corpuscle hemoglobin concentration (MCHC), mean corpuscle hemoglobin (MCH), mean corpuscle volume (MCV) mean platelet volume (MPV), basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, monocytes, platelet count, Red blood cell (RBC) count, reticulocytes, White Blood Cell (WBC) count. Laboratory values were as per local labs per site with own normal ranges. Values above range were reported as high and values below range as low. Data for worst post Baseline were reported. NA indicates that data were not available as standard deviation could not be calculated for a single participant.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range MCHC, to High,n=1,2,7,5,3,2,10,6	1 Participants	0 Participants	3 Participants	2 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range MCV, to High,n=1,2,7,5,6,4,10,6	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range RBC, to High,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Basophils, to Low,n=1,2,7,4,2,2,9,5	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Basophils, to High,n=1,2,7,4,2,2,9,5	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Eosinophils, to Low,n=1,2,7,4,2,2,8,5	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Eosinophils, to High,n=1,2,7,4,2,2,8,5	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Hemoglobin, to Low,n=0,0,0,0,2,0,0,1	—	—	—	—	0 Participants	—	—	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Hemoglobin, to High,n=0,0,0,0,2,0,0,1	—	—	—	—	0 Participants	—	—	1 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Hematocrit, to Low,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Hematocrit, to High,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range MCHC, to Low,n=1,2,7,5,3,2,10,6	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range MCH, to Low,n=1,2,7,5,3,2,10,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range MCH, to High,n=1,2,7,5,3,2,10,6	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range MCV, to Low,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Monocytes, to Low,n=1,2,7,4,2,2,10,6	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Monocytes, to High,n=1,2,7,4,2,2,10,6	0 Participants	1 Participants	4 Participants	0 Participants	1 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range MPV, to Low,n=0,0,0,3,6,3,7,6	—	—	—	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range MPV, to High,n=0,0,0,3,6,3,7,6	—	—	—	1 Participants	2 Participants	0 Participants	3 Participants	4 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Nucleated RBC, to Low,n=0,0,0,1,1,0,1,0	—	—	—	0 Participants	0 Participants	—	0 Participants	—
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Nucleated RBC, to High,n=0,0,0,1,1,0,1,0	—	—	—	0 Participants	0 Participants	—	0 Participants	—
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range RBC, to Low,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Reticulocytes, to Low,n=1,2,7,4,2,2,7,5	0 Participants	2 Participants	5 Participants	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range Reticulocytes, to High,n=1,2,7,4,2,2,7,5	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for analysis of hematology parameters based on common terminology criteria for adverse events (CTCAE) version 4.0, where Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe or medically significant; Grade 4 is life threatening consequences. Data for any grade increase worst-case on-therapy has been provided.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Number of Participants With Hematology Toxicity Grade Changes From Baseline Hg anemia,n=1,2,7,5,6,4,10,6	1 Participants	2 Participants	5 Participants	4 Participants	1 Participants	2 Participants	4 Participants	3 Participants
Number of Participants With Hematology Toxicity Grade Changes From Baseline Total Neu,n=1,2,7,4,2,2,10,6	1 Participants	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Hematology Toxicity Grade Changes From Baseline Platelet,n=1,2,7,5,6,4,10,6	1 Participants	1 Participants	4 Participants	3 Participants	1 Participants	2 Participants	3 Participants	3 Participants
Number of Participants With Hematology Toxicity Grade Changes From Baseline WBC,n=1,2,7,5,6,4,10,6	1 Participants	2 Participants	2 Participants	4 Participants	5 Participants	1 Participants	5 Participants	1 Participants
Number of Participants With Hematology Toxicity Grade Changes From Baseline Hg increase,n=1,2,7,5,6,4,10,6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Hematology Toxicity Grade Changes From Baseline Lymph increase,n=1,2,7,4,2,2,10,6	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	1 Participants
Number of Participants With Hematology Toxicity Grade Changes From Baseline Lymph decrease,n=1,2,7,4,2,2,10,6	1 Participants	2 Participants	2 Participants	3 Participants	1 Participants	2 Participants	5 Participants	2 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population. Only those participants with available data at the specified time points were analyzed (represented by n=X in category titles).

SBP and DBP were measured after resting for 5 minutes in semi-supine position. Vital signs were graded according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4. An increase is defined as an increase in CTCAE grade relative to Baseline grade. For SBP Grade 0 (<120 millimeters of mercury [mmHg]), Grade 1 (120-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (>=160 mmHg). For DBP Grade 0 (<80 mmHg), Grade 1 (80-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (>=100 mmHg). Data for worst-case post Baseline is reported.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Number of Participants With Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP,Any Grade Increase; n=1, 1, 3, 4, 6, 2, 5, 3	1 Participants	1 Participants	3 Participants	4 Participants	6 Participants	2 Participants	5 Participants	3 Participants
Part 1: Number of Participants With Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP,Increase to Grade 2;n=1, 1, 3, 4, 6, 2, 5, 3	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants	1 Participants	4 Participants	3 Participants
Part 1: Number of Participants With Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) SBP,Increase to Grade 3;n=1, 1, 3, 4, 6, 2, 5, 3	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Part 1: Number of Participants With Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP,Increase to Grade 2;n=1, 2, 3, 2, 4, 1, 3, 2	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants
Part 1: Number of Participants With Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP,Any Grade Increase;n=1, 2, 3, 2, 4, 1, 3, 2	1 Participants	2 Participants	3 Participants	2 Participants	4 Participants	1 Participants	3 Participants	2 Participants
Part 1: Number of Participants With Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) DBP,Increase to Grade 3;n=1, 2, 3, 2, 4, 1, 3, 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population. Only those participants with available data at the specified time points were analyzed.

Heart rate was measured after restings for 5 minutes in semi-supine position. Data for participants with heart rate decreased to < 60 beats per minute (bpm), normal or no change, increase to > 100 bpm. Data for worst post Baseline were reported.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Number of Participants With Change From Baseline in Heart Rate Decrease to <60	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change From Baseline in Heart Rate Change to Normal or No Change	0 Participants	2 Participants	1 Participants	4 Participants	4 Participants	4 Participants	5 Participants	3 Participants
Part 1: Number of Participants With Change From Baseline in Heart Rate Increase to >100	1 Participants	0 Participants	6 Participants	1 Participants	2 Participants	0 Participants	5 Participants	3 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population.

Temperature was measured after resting for 5 minutes in semi-supine position. Data for participants with temperature decreased to <=35 Celsius, normal or no change, increase to >=38 Celsius at worst-case post Baseline is reported.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Number of Participants With Change From Baseline in Temperature Decrease to <=35	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change From Baseline in Temperature Change to Normal or No Change	1 Participants	2 Participants	4 Participants	4 Participants	5 Participants	4 Participants	9 Participants	6 Participants
Part 1: Number of Participants With Change From Baseline in Temperature Increase to >=38	0 Participants	0 Participants	3 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population.

Respiration rate was measured after resting for 5 minutes in semi-supine position. Data for worst case post-Baseline has been reported. Number of participants with respiratory rate decrease to <12 and increase to >25 has been reported.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Number of Participants With Change From Baseline in Respiratory Rate Decrease to <12	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Part 1: Number of Participants With Change From Baseline in Respiratory Rate Increase to >25	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population. Only those participants with available data at the specified time points were analyzed.

A single 12-lead ECG was performed in semi-recumbent or supine position after 5 minutes of rest for the participant. An ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT intervals was used. Number of participants with any visit post-Baseline abnormal clinically significant findings and abnormal not clinically significant findings in ECG results has been reported.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Abnormal - clinically significant	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants
Part 1: Number of Participants With Abnormal Electrocardiograms (ECGs) Findings Abnormal - not clinically significant	1 Participants	2 Participants	7 Participants	4 Participants	4 Participants	2 Participants	4 Participants	6 Participants

PRIMARY outcome

Timeframe: Median of 4 weeks of drug exposure

Population: All Treated Subjects Population. The data was not collected as it was not captured within the case report form (CRF).

Data for participants with abnormal physical examinations parameters was planned to be recorded.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 14 months

Population: All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study

Objective response rate defined as the percentage of participants who achievied complete remission (CR), partial remission (PR), CRp (as per CR but platelet count <100 x 10^9/L) and morphologic leukemia free state per response criteria. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1

Population: PK Population comprised of all treated participants for whom a PK sample was obtained and analyzed. Only those participants with available data at the specified time points were analyzed (represented by n=X in category titles).

Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis. NA indicates that data were not available as geometric co-efficient of variation could not be calculated for a single participant.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and From Time Zero (Pre-dose) Extrapolated to Infinite Time [(AUC(0-inf)] After Single Dose Administration AUC(0-t) n=1, 2, 7, 5, 6,4, 9,5	30.9457 Hour*nanograms per milliliter Geometric Coefficient of Variation NA NA indicates that data were not available as geometric co-efficient could not be calculated for a single participant.	62.7579 Hour*nanograms per milliliter Geometric Coefficient of Variation 40.6	211.1387 Hour*nanograms per milliliter Geometric Coefficient of Variation 34.8	549.9557 Hour*nanograms per milliliter Geometric Coefficient of Variation 64.3	738.1552 Hour*nanograms per milliliter Geometric Coefficient of Variation 77.6	974.7759 Hour*nanograms per milliliter Geometric Coefficient of Variation 24.2	97.6341 Hour*nanograms per milliliter Geometric Coefficient of Variation 38.8	968.7825 Hour*nanograms per milliliter Geometric Coefficient of Variation 36.1
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and From Time Zero (Pre-dose) Extrapolated to Infinite Time [(AUC(0-inf)] After Single Dose Administration AUC(0-inf); n=1, 2, 7, 5, 6,4, 8,5	36.8470 Hour*nanograms per milliliter Geometric Coefficient of Variation NA NA indicates that data were not available as geometric co-efficient could not be calculated for a single participant.	72.7180 Hour*nanograms per milliliter Geometric Coefficient of Variation 31.4	222.0837 Hour*nanograms per milliliter Geometric Coefficient of Variation 35.1	600.6492 Hour*nanograms per milliliter Geometric Coefficient of Variation 61.9	791.2295 Hour*nanograms per milliliter Geometric Coefficient of Variation 74.1	1125.8508 Hour*nanograms per milliliter Geometric Coefficient of Variation 29.7	105.4513 Hour*nanograms per milliliter Geometric Coefficient of Variation 41.7	1101.4318 Hour*nanograms per milliliter Geometric Coefficient of Variation 41.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1

Population: PK Population. Only those participants with available data at the specified time points were analyzed.

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. NA indicates that data were not available as geometric co-efficient could not be calculated for a single participant.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=8 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=5 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: AUC Over the Dosing Interval (0-tau) After Single Dose Administration	22.2630 Hour*nanograms per milliliter Geometric Coefficient of Variation NA NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.	44.0692 Hour*nanograms per milliliter Geometric Coefficient of Variation 45.5	169.5072 Hour*nanograms per milliliter Geometric Coefficient of Variation 35.1	483.7209 Hour*nanograms per milliliter Geometric Coefficient of Variation 62.2	638.4389 Hour*nanograms per milliliter Geometric Coefficient of Variation 70.3	870.8045 Hour*nanograms per milliliter Geometric Coefficient of Variation 21.0	80.2478 Hour*nanograms per milliliter Geometric Coefficient of Variation 48.4	885.8174 Hour*nanograms per milliliter Geometric Coefficient of Variation 24.1

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 15

Population: PK Population. Only those participants with available data at the specified time points were analyzed.

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=4 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=4 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=2 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=6 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=4 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and AUC Over the Dosing Interval (0-tau) After Repeated Administration AUC (0-tau)	37.6629 Hour*nanograms per milliliter Geometric Coefficient of Variation NA NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.	82.8980 Hour*nanograms per milliliter Geometric Coefficient of Variation 31.5	221.6595 Hour*nanograms per milliliter Geometric Coefficient of Variation 48.2	699.1461 Hour*nanograms per milliliter Geometric Coefficient of Variation 62.3	661.7915 Hour*nanograms per milliliter Geometric Coefficient of Variation 58.0	1152.0895 Hour*nanograms per milliliter Geometric Coefficient of Variation 24.9	142.6193 Hour*nanograms per milliliter Geometric Coefficient of Variation 35.0	904.2889 Hour*nanograms per milliliter Geometric Coefficient of Variation 30.0
Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and AUC Over the Dosing Interval (0-tau) After Repeated Administration AUC (0-t)	22.0069 Hour*nanograms per milliliter Geometric Coefficient of Variation NA NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.	82.6381 Hour*nanograms per milliliter Geometric Coefficient of Variation 31.2	221.5336 Hour*nanograms per milliliter Geometric Coefficient of Variation 48.2	692.8434 Hour*nanograms per milliliter Geometric Coefficient of Variation 62.3	623.2032 Hour*nanograms per milliliter Geometric Coefficient of Variation 63.9	1158.6530 Hour*nanograms per milliliter Geometric Coefficient of Variation 27.3	132.0625 Hour*nanograms per milliliter Geometric Coefficient of Variation 38.4	904.0276 Hour*nanograms per milliliter Geometric Coefficient of Variation 30.2

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15

Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK2879552 Day 15,n=1,2,4,4,6,2,6,4	4.3920 Nanograms per milliliter Geometric Coefficient of Variation NA NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.	11.5411 Nanograms per milliliter Geometric Coefficient of Variation 60.1	40.1989 Nanograms per milliliter Geometric Coefficient of Variation 52.0	83.2978 Nanograms per milliliter Geometric Coefficient of Variation 32.9	103.0141 Nanograms per milliliter Geometric Coefficient of Variation 65.7	224.2444 Nanograms per milliliter Geometric Coefficient of Variation 17.7	16.7684 Nanograms per milliliter Geometric Coefficient of Variation 37.0	144.6871 Nanograms per milliliter Geometric Coefficient of Variation 25.4
Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK2879552 Day 1,n=1,2,7,5,6,4,9,5	4.0660 Nanograms per milliliter Geometric Coefficient of Variation NA NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.	7.5501 Nanograms per milliliter Geometric Coefficient of Variation 34.2	28.5460 Nanograms per milliliter Geometric Coefficient of Variation 32.0	65.5650 Nanograms per milliliter Geometric Coefficient of Variation 59.8	98.6033 Nanograms per milliliter Geometric Coefficient of Variation 73.1	134.8388 Nanograms per milliliter Geometric Coefficient of Variation 12.8	13.3889 Nanograms per milliliter Geometric Coefficient of Variation 63.3	142.8826 Nanograms per milliliter Geometric Coefficient of Variation 28.6

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=8 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=5 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Apparent Terminal Phase Half-life (t½)	34.6647 Hours Geometric Coefficient of Variation NA NA indicates that data were not available as geometric coefficient of variation could not be calculated for a single participant.	29.7715 Hours Geometric Coefficient of Variation 37.3	19.6564 Hours Geometric Coefficient of Variation 15.9	11.2045 Hours Geometric Coefficient of Variation 26.0	12.4020 Hours Geometric Coefficient of Variation 26.5	15.9502 Hours Geometric Coefficient of Variation 20.6	14.9631 Hours Geometric Coefficient of Variation 38.9	10.5340 Hours Geometric Coefficient of Variation 47.8

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15

Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. NA indicates that data were not available as standard deviation could not be calculated for a single participant.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Time of Occurrence of Cmax (Tmax) of GSK2879552 Day 1, n=1, 2, 7, 5, 6, 4, 9, 5	0.983 Hours Interval 0.983 to 0.983	0.7500 Hours Interval 0.5 to 1.0	1.0000 Hours Interval 0.5 to 2.0	0.9667 Hours Interval 0.467 to 1.5	1.2750 Hours Interval 0.5 to 2.5	0.6667 Hours Interval 0.5 to 1.033	1.0000 Hours Interval 0.333 to 1.75	1.0000 Hours Interval 0.5 to 1.0
Part 1: Time of Occurrence of Cmax (Tmax) of GSK2879552 Day 15, n= 1, 2, 4, 4, 6, 2, 6, 4	1.0000 Hours Interval 1.0 to 1.0	1.0000 Hours Interval 0.5 to 1.5	0.7833 Hours Interval 0.5 to 2.017	1.5833 Hours Interval 0.5 to 1.983	0.8167 Hours Interval 0.5 to 3.05	0.3833 Hours Interval 0.267 to 0.5	0.9917 Hours Interval 0.5 to 3.033	1.3000 Hours Interval 0.5 to 2.0

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15

Population: PK Population. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. Accumulation ratio was determined dividing AUC (0-tau) on Day 15 by AUC (0-tau) on Day 1. The ratio of accumulation of GSK2879552 was estimated by calculating the ratio of the geometric least squares (GLS) means of the AUC(0-tau) between Day 15 and Day 1 for all dose levels and the corresponding 90 percent confidence interval (CI) for each ratio.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=2 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=4 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=4 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=6 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=2 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=6 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=4 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1: Accumulation Ratio for GSK2879552	1.881 Ratio Interval 1.072 to 3.3	1.367 Ratio Interval 1.208 to 1.547	1.319 Ratio Interval 1.099 to 1.584	1.037 Ratio Interval 0.792 to 1.356	1.388 Ratio Interval 0.9 to 2.141	1.750 Ratio Interval 1.449 to 2.113	1.073 Ratio Interval 0.86 to 1.338	—

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15

Population: PK Population.

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. The time invariance of GSK2879552 was estimated by calculating the ratio of the GLS means of the AUC (0-tau) between Day 15 and Day 1 for all dose levels and the corresponding 90 percent CI for each ratio.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=4 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=4 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=2 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=6 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=4 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1:Time Invariance	—	1.140 Ratio Interval 1.136 to 1.144	1.030 Ratio Interval 0.891 to 1.191	1.042 Ratio Interval 0.874 to 1.242	0.836 Ratio Interval 0.657 to 1.065	1.167 Ratio Interval 0.639 to 2.13	1.346 Ratio Interval 1.164 to 1.556	0.845 Ratio Interval 0.625 to 1.143

SECONDARY outcome

Timeframe: Median of 4 weeks drug response

Population: All Treated Subjects.

Objective response rate is defined as the percentage of participants who achieved CR, PR, as per CR but platelet count <100 x 10^9/L and morphologic leukemia free state per response criteria.

Outcome measures

Measure	Part 1:GSK2879552 1mg QD n=1 Participants Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 Participants Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 Participants Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 Participants Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 Participants Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 Participants Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 Participants Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 Participants Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.
Part 1:Percentage of Participants With Objective Response	0 Percentage of Participants Interval 0.0 to 97.5	0 Percentage of Participants Interval 0.0 to 84.2	0 Percentage of Participants Interval 0.0 to 41.0	0 Percentage of Participants Interval 0.0 to 52.2	17 Percentage of Participants Interval 0.4 to 64.1	0 Percentage of Participants Interval 0.0 to 60.2	10 Percentage of Participants Interval 0.3 to 44.5	0 Percentage of Participants Interval 0.0 to 45.9

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1and Day 15

Population: PK Population. Plasma samples were not quantifiable for ATRA at all end points and hence the PK parameters could not be derived.

Blood samples were collected at indicated time points. The Pharmacokinetic (PK) parameters were calculated by non-compartmental analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15

Population: PK Population. Plasma samples were not quantifiable for ATRA at all end points and hence the PK parameters could not be derived.

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15

Population: PK Population. Plasma samples were not quantifiable for ATRA at all end points and hence the PK parameters could not be derived.

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 1 and 15

Population: PK Population. Plasma samples were not quantifiable for ATRA at all end points and hence the PK parameters could not be derived.

Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

The number of participants who had any dose reduction or delay have been presented. All dose reductions were due to AEs. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to toxicities has been presented. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

Data was not collected for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

Data was not collected for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

Data was not collected for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Treated Subjects Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 and 3 hours post dose), Days 4, 8 (pre-dose), Day 15 (pre-dose, 0.5, 1, 4, 6 hours), Weeks 4, 5, 6, 7, 8 and every 4 weeks up to Week 48

Population: PK Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (pre-dose, 0.5 and 3 hours post dose), Days 4, 8 (pre-dose), Day 15 (pre-dose, 0.5, 1, 4, 6 hours), Weeks 4, 5, 6, 7, 8 and every 4 weeks up to Week 48

Population: PK Population. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Participants. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Participants. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Participants. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 14 months

Population: All Participants. Data for this endpoint was not collected as this study was terminated early during Part 1 as the risk benefit in relapsed/refractory AML did not favor continuation of the study.

This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.

Outcome measures

Outcome data not reported

Adverse Events

Part 1:GSK2879552 1mg QD

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: GSK2879552 2mg QD

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: GSK2879552 4mg QD

Serious events: 7 serious events

Other events: 6 other events

Deaths: 1 deaths

Part 1: GSK2879552 8mg QD

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1: GSK2879552 12mg QD

Serious events: 6 serious events

Other events: 6 other events

Deaths: 3 deaths

Part 1: GSK2879552 20mg QD

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day

Serious events: 8 serious events

Other events: 10 other events

Deaths: 2 deaths

Part 1: GSK2879552 20mg QD PK/PD Expansion

Serious events: 5 serious events

Other events: 6 other events

Deaths: 1 deaths

Part 2: Expansion Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1:GSK2879552 1mg QD n=1 participants at risk Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 participants at risk Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 participants at risk Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 participants at risk Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 participants at risk Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 participants at risk Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 participants at risk Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 participants at risk Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.	Part 2: Expansion Cohort In Part 2, participants were planned to receive the recommended Phase 2 dose of GSK2879552 orally once daily in fasted condition with approximately 200 mL of water alone or in combination with ATRA.
Blood and lymphatic system disorders Febrile neutropenia	100.0% 1/1 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	100.0% 2/2 • Number of events 6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	42.9% 3/7 • Number of events 5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	60.0% 3/5 • Number of events 6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 3/6 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 4/10 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 3/6 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Cellulitis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Pneumonia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Anorectal cellulitis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Escherichia sepsis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Influenza	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Klebsiella bacteraemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Lung infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Pseudomonal bacteraemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Parainfluenzae virus infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Pulmonary mycosis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Septic shock	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Soft tissue infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Viral infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Nausea	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Oral pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Pancreatitis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Toothache	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Injury, poisoning and procedural complications Subarachnoid haemorrhage	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Troponin I increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Cognitive disorder	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Encephalopathy	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Psychiatric disorders Delirium	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Psychiatric disorders Hallucination	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Cardiac disorders Cardiomyopathy	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Pyrexia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Vascular disorders Haematoma	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.

Other adverse events

Measure	Part 1:GSK2879552 1mg QD n=1 participants at risk Participants received GSK2879552 1 mg orally QD in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD n=2 participants at risk Participants received GSK2879552 2 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 4mg QD n=7 participants at risk Participants received GSK2879552 4 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 8mg QD n=5 participants at risk Participants received GSK2879552 8 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 12mg QD n=6 participants at risk Participants received GSK2879552 12 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 20mg QD n=4 participants at risk Participants received GSK2879552 20 mg orally once daily in fasted condition with approximately 200 mL of water.	Part 1: GSK2879552 2mg QD/ATRA 45mg/m^2/Day n=10 participants at risk Participants received GSK2879552 2 mg capsule orally once daily in fasted condition with approximately 200 mL of water in combination with ATRA at a dose of 45 mg/m\^2/day.	Part 1: GSK2879552 20mg QD PK/PD Expansion n=6 participants at risk Participants received GSK2879552 20 mg capsule orally once daily in fasted condition with approximately 200 mL of water in PK/PD Expansion cohort to collect adequate data on safety, PK or PD.	Part 2: Expansion Cohort In Part 2, participants were planned to receive the recommended Phase 2 dose of GSK2879552 orally once daily in fasted condition with approximately 200 mL of water alone or in combination with ATRA.
Nervous system disorders Headache	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Nausea	100.0% 1/1 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	71.4% 5/7 • Number of events 6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	60.0% 3/5 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	60.0% 6/10 • Number of events 6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Vomiting	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 2/5 • Number of events 5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	66.7% 4/6 • Number of events 6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Constipation	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 4/10 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 2/5 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 4/10 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Angina bullosa haemorrhagica	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Mouth ulceration	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	28.6% 2/7 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Anal incontinence	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Gingival bleeding	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Abdominal distension	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Oral pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 2/4 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Toothache	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Ascites	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Chapped lips	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Dental discomfort	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Dry mouth	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Gastric ulcer	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Glossodynia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Lip swelling	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Oral disorder	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Gastrointestinal disorders Tongue ulceration	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	28.6% 2/7 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	60.0% 3/5 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	30.0% 3/10 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	60.0% 3/5 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 4/10 • Number of events 5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 2/5 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Fluid overload	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	30.0% 3/10 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Acidosis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Fluid retention	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Metabolism and nutrition disorders Pseudohyponatraemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	100.0% 2/2 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	28.6% 2/7 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 2/5 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 3/6 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	30.0% 3/10 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Localised oedema	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	28.6% 2/7 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Oedema peripheral	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Pyrexia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 3/6 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Non-cardiac chest pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	30.0% 3/10 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	28.6% 2/7 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Influenza like illness	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Mucosal inflammation	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Chills	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Catheter site erythema	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Catheter site pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Catheter site vesicles	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Cyst	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Catheter site haemorrhage	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Face oedema	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Facial pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Hypothermia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Nodule	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
General disorders Oedema	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 3/6 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Blister	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Blood blister	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Skin and subcutaneous tissue disorders Rash	100.0% 1/1 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	28.6% 2/7 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	30.0% 3/10 • Number of events 5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	66.7% 4/6 • Number of events 6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Device related infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Cellulitis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 2/5 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Lung infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Oral herpes	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Sepsis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Staphylococcal infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Urinary tract infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Aspergillus infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Bacteraemia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Clostridium difficile infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Conjunctivitis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Hepatitis B	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Herpes zoster	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Localised infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Pneumonia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Pulmonary mycosis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Respiratory tract infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Tooth infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Vaginal abscess	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Infections and infestations Wound infection	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Dizziness	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Lethargy	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Disturbance in attention	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Syncope	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Arachnoid web	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Cognitive disorder	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Dysarthria	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Dysgeusia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Hypoaesthesia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Loss of consciousness	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Presyncope	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Sciatica	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Nervous system disorders Serotonin syndrome	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	30.0% 3/10 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Injury, poisoning and procedural complications Contusion	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Injury, poisoning and procedural complications Laceration	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations International normalised ratio increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Platelet count decreased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 2/5 • Number of events 3 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Blood creatinine increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Neutrophil count decreased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations White blood cell count decreased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Alanine aminotransferase increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations White blood cell count increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	100.0% 1/1 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Blood bilirubin increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Lymphocyte count increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Clostridium test positive	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Oxygen saturation decreased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Vitamin B12 decreased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Troponin I increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Investigations Troponin increased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Vascular disorders Hypotension	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	28.6% 2/7 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 2/5 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	30.0% 3/10 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Vascular disorders Haematoma	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Vascular disorders Haemorrhage	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	33.3% 2/6 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Bone pain	100.0% 1/1 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Psychiatric disorders Confusional state	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 4/10 • Number of events 4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Psychiatric disorders Insomnia	100.0% 1/1 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Psychiatric disorders Agitation	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Psychiatric disorders Anxiety	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Psychiatric disorders Depressed mood	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Psychiatric disorders Delirium	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Psychiatric disorders Hallucination	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Blood and lymphatic system disorders Anaemia	100.0% 1/1 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	40.0% 2/5 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 2/4 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	50.0% 1/2 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Blood and lymphatic system disorders Hyperleukocytosis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Blood and lymphatic system disorders Neutropenia	100.0% 1/1 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Eye disorders Conjunctival haemorrhage	100.0% 1/1 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Eye disorders Dry eye	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Eye disorders Eye haematoma	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Eye disorders Eye swelling	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Eye disorders Photophobia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Eye disorders Visual impairment	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Cardiac disorders Tachycardia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Cardiac disorders Pericardial effusion	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Cardiac disorders Sinus bradycardia	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Renal and urinary disorders Urinary incontinence	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Renal and urinary disorders Acute kidney injury	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Renal and urinary disorders Pollakiuria	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 2/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Renal and urinary disorders Incontinence	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Renal and urinary disorders Urinary retention	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Ear and labyrinth disorders Hypoacusis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	25.0% 1/4 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Ear and labyrinth disorders Deafness	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Ear and labyrinth disorders Deafness bilateral	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Ear and labyrinth disorders Ear discomfort	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Ear and labyrinth disorders Excessive cerumen production	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Reproductive system and breast disorders Penile haemorrhage	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	20.0% 1/5 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Reproductive system and breast disorders Scrotal disorder	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	10.0% 1/10 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Endocrine disorders Hyperthyroidism	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Hepatobiliary disorders Cholelithiasis	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	14.3% 1/7 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.
Surgical and medical procedures Endodontic procedure	0.00% 0/1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/2 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/7 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/5 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	16.7% 1/6 • Number of events 1 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/4 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/10 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	0.00% 0/6 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.	— 0/0 • Adverse events were collected from start of the study up to 3 years All Treated Subjects Population was used to collect adverse events. AEs and SAEs were not collected in Part 2 of the study as no participants were enrolled due to early termination during Part 1.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER