Trial Outcomes & Findings for Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC) (NCT NCT00788957)

NCT ID: NCT00788957

Last Updated: 2024-08-07

Results Overview

A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 177 participants
• Primary outcome timeframe: 7 weeks
• Results posted on: 2024-08-07

Participant Flow

First patient enrolled 27 October 2008; last patient enrolled 05 February 2010. In Part 1, participants with wild-type KRAS metastatic colorectal cancer received open-label rilotumumab and panitumumab to identify a tolerable dose of rilotumumab for Part 2 of the study. Participants enrolled in Part 1 were not eligible for randomization in Part 2.

In Part 2 participants were randomized in a 1:1:1 ratio to the 3 double-blinded treatment arms. In Part 3, participants randomized to Panitumumab Alone in Part 2 and with disease progression or intolerability were re-randomized 1:1 into 2 double-blind groups. Clinically significant laboratory findings were considered adverse events, so the protocol endpoint "Incidence of all AEs and clinical laboratory abnormalities" was not analyzed separately but was included in the AE data

Participant milestones

Measure	Part 1: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab Alone Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 3: Rilotumumab Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.	Part 3: Ganitumab Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
Part 1 STARTED	11	0	0	0	0	0
Part 1 COMPLETED	2	0	0	0	0	0
Part 1 NOT COMPLETED	9	0	0	0	0	0
Part 2 STARTED	0	48	48	46	0	0
Part 2 COMPLETED	0	6	4	5	0	0
Part 2 NOT COMPLETED	0	42	44	41	0	0
Part 3 STARTED	0	0	0	0	13	11
Part 3 COMPLETED	0	0	0	0	4	1
Part 3 NOT COMPLETED	0	0	0	0	9	10

Reasons for withdrawal

Measure	Part 1: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab Alone Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 3: Rilotumumab Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.	Part 3: Ganitumab Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
Part 1 Death	8	0	0	0	0	0
Part 1 Lost to Follow-up	1	0	0	0	0	0
Part 2 Withdrawal by Subject	0	9	5	3	0	0
Part 2 Death	0	32	35	37	0	0
Part 2 Lost to Follow-up	0	0	3	0	0	0
Part 2 On-study at time of data cut-off	0	1	1	1	0	0
Part 3 Withdrawal by Subject	0	0	0	0	0	2
Part 3 Death	0	0	0	0	8	8
Part 3 On-study at time of data cut-off	0	0	0	0	1	0

Baseline Characteristics

Panitumumab Combination Study With Rilotumumab or Ganitumab in Wild-type Kirsten Rat Sarcoma Virus Oncogene Homolog (KRAS) Metastatic Colorectal Cancer (mCRC)

Baseline characteristics by cohort

Measure	Part 1: Panitumumab + Rilotumumab n=11 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab Alone n=48 Participants Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=46 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 3: Rilotumumab n=13 Participants Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.	Part 3: Ganitumab n=11 Participants Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.	Total n=177 Participants Total of all reporting groups
Age, Continuous Part 1 Participants	56.5 years STANDARD_DEVIATION 13.8 • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=4 Participants	NA years STANDARD_DEVIATION NA • n=21 Participants	NA years STANDARD_DEVIATION NA • n=10 Participants	56.5 years STANDARD_DEVIATION 13.8 • n=115 Participants
Age, Continuous Part 2 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	55.0 years STANDARD_DEVIATION 12.5 • n=7 Participants	62.1 years STANDARD_DEVIATION 7.5 • n=5 Participants	62.0 years STANDARD_DEVIATION 9.7 • n=4 Participants	NA years STANDARD_DEVIATION NA • n=21 Participants	NA years STANDARD_DEVIATION NA • n=10 Participants	59.7 years STANDARD_DEVIATION 10.6 • n=115 Participants
Age, Continuous Part 3 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=4 Participants	54.8 years STANDARD_DEVIATION 13.9 • n=21 Participants	52.0 years STANDARD_DEVIATION 11.3 • n=10 Participants	53.5 years STANDARD_DEVIATION 12.6 • n=115 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	21 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	75 Participants n=115 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	28 Participants n=7 Participants	29 Participants n=5 Participants	25 Participants n=4 Participants	10 Participants n=21 Participants	5 Participants n=10 Participants	102 Participants n=115 Participants
Race/Ethnicity, Customized White or Caucasian	11 participants n=5 Participants	45 participants n=7 Participants	47 participants n=5 Participants	45 participants n=4 Participants	13 participants n=21 Participants	10 participants n=10 Participants	171 participants n=115 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	2 participants n=115 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	1 participants n=115 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	0 participants n=10 Participants	1 participants n=115 Participants
Race/Ethnicity, Customized Other	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	2 participants n=115 Participants
Subjects With Wild-Type KRAS Metastatic Colorectal Cancer	11 Participants n=5 Participants	48 Participants n=7 Participants	48 Participants n=5 Participants	46 Participants n=4 Participants	13 Participants n=21 Participants	11 Participants n=10 Participants	177 Participants n=115 Participants

PRIMARY outcome

Timeframe: 7 weeks

Population: The first 6 DLT evaluable participants, including participants who received at least 2 doses of panitumumab and rilotumumab as scheduled (ie, Week 1 and 3) and have a minimum 28 days follow-up for safety or, have received at least 1 dose of panitumumab and rilotumumab and had a DLT within the first 28 days on study.

A DLT is defined as any grade 3 or 4 rilotumumab-related or combination (panitumumab and rilotumumab)-related adverse event or laboratory abnormality that is deemed clinically significant by the investigator

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=6 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Part 1: Number of Participants With Dose-limiting Toxicities (DLT)	0 participants	—	—

PRIMARY outcome

Timeframe: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.

Population: Efficacy analysis set (enrolled participants who received at least one dose of respective investigational product in the corresponding parts of the study) with measurable baseline disease.

An objective response is defined as a confirmed complete (CR) or partial response (PR) no less than 4 weeks after the criteria for response are first met, determined by the investigator considering the radiologic response of all existing target and non-target lesions, evidence of new lesions, and cytology evaluation (as appropriate) according to the Modified-Response Evaluation Criteria In Solid Tumors (RECIST) v1.0 criteria: CR: Disappearance of all target and non-target and no new lesions. PR: At least a 30% decrease in the size of target lesions with no increase in non-target lesions, or, the disappearance of all target lesions and persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders. Tumor assessments up to the initiation of another anti-tumor therapy including the Part 3 treatment, if applicable, were used.

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=46 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Part 2: Percentage of Participants With an Objective Response	21 percentage of participants Interval 10.5 to 35.0	31 percentage of participants Interval 18.7 to 46.3	22 percentage of participants Interval 10.9 to 36.4

SECONDARY outcome

Timeframe: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.

Population: Only subjects with confirmed response

Time from the confirmed objective response to disease progression per the modified RECIST v1.0 criteria.

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=10 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=15 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=10 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Duration of Response - Part 2	3.7 Months Interval 3.6 to Not estimable as number of responding subjects and number with events was too small to calculate upper confidence interval.	5.1 Months Interval 3.7 to 5.6	3.7 Months Interval 3.6 to 5.8

SECONDARY outcome

Timeframe: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.

Population: Only subjects with confirmed response

Time from the first dose of investigational product to the date of first confirmed objective response. Calculated only for subject with a confirmed objective response

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=10 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=15 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=10 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Time to Response - Part 2	1.8 Months Interval 1.6 to 2.5	1.6 Months Interval 1.6 to 1.7	1.7 Months Interval 1.6 to 1.7

SECONDARY outcome

Timeframe: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.

The incidence of confirmed objective response or stable disease. Stable disease cannot be established prior to study day 49 (calculated from the date of first dose of investigational product), ie, the earliest protocol scheduled tumor assessment

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=46 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Disease Control Rate - Part 2	56 percentage of participants Interval 41.0 to 71.0	71 percentage of participants Interval 56.0 to 83.0	61 percentage of participants Interval 45.0 to 75.0

SECONDARY outcome

Timeframe: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.

Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=46 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Progression-free Survival (PFS) - Part 2	3.7 Months Interval 2.5 to 5.3	5.2 Months Interval 3.6 to 5.4	5.3 Months Interval 2.7 to 5.7

SECONDARY outcome

Timeframe: From the date of first dose until the data cut-off date of 23 July 2010. Up to 56 weeks.

Time from the first dose of investigational product to the date of disease progression per the modified RECIST v1.0 criteria or death during the treatment period (from the first to last dose of investigational product). Radiographic progression within 28 days since last dose of study therapy (last component of combination therapy) up to the initiation of another anti-tumor therapy, including the Part 3 treatment, if applicable, or death within 28 days since last dose of study therapy.

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=46 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
On-treatment Progression-free Survival (PFS) - Part 2	3.8 Months Interval 2.5 to 5.3	5.3 Months Interval 3.6 to 5.4	5.3 Months Interval 2.7 to 5.7

SECONDARY outcome

Timeframe: From the date of first dose until the data cut-off date of 23 July 2010. Median follow-up time was 30 weeks.

The interval in months from the first dose of investigational product to the date of death.

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=46 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Overall Survival - Part 2	NA Months Interval 8.6 to Median and upper CIs are not estimable due to small number of subjects with events in time period.	NA Months Interval 9.6 to Median and upper CIs are not estimable due to small number of subjects with events in time period.	NA Months Interval 7.1 to Median and upper CIs are not estimable due to small number of subjects with events in time period.

SECONDARY outcome

Timeframe: 14 days

Population: PK population

Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=6 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Cmin, Cmax of Panitumumab Cmin	42.5 μg/mL Interval 32.2 to 105.0	—	—
Cmin, Cmax of Panitumumab Cmax	223 μg/mL Interval 166.0 to 276.0	—	—

SECONDARY outcome

Timeframe: 14 days

Population: PK population

Cmin = minimum drug concentration during a dosing interval; Cmax = maximum observed drug concentration during a dosing interval

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=6 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Cmin, Cmax, for Rilotumumab Cmin	120 μg/mL Interval 86.7 to 171.0	—	—
Cmin, Cmax, for Rilotumumab Cmax	306 μg/mL Interval 264.0 to 488.0	—	—

SECONDARY outcome

Timeframe: Up to 23 weeks

Population: PK population Measure of dispersion is %CV

Cmin = minimum drug concentration during a dosing interval

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=43 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=42 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=44 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Cmin for Panitumumab - Part 2 Week 3	19.8 μg/mL Standard Deviation 80.3	22.8 μg/mL Standard Deviation 73.5	17.2 μg/mL Standard Deviation 56.5
Cmin for Panitumumab - Part 2 Week 5	34.8 μg/mL Standard Deviation 58.9	37.9 μg/mL Standard Deviation 52.5	29.8 μg/mL Standard Deviation 55.7
Cmin for Panitumumab - Part 2 Week 7	39.9 μg/mL Standard Deviation 62.2	45.2 μg/mL Standard Deviation 50.4	37.4 μg/mL Standard Deviation 54.5
Cmin for Panitumumab - Part 2 Week 13	63.5 μg/mL Standard Deviation 43.0	63.4 μg/mL Standard Deviation 45.2	51.4 μg/mL Standard Deviation 63.1
Cmin for Panitumumab - Part 2 Week 23	82.1 μg/mL Standard Deviation 28.2	62.1 μg/mL Standard Deviation 44.3	54.8 μg/mL Standard Deviation 53.8

SECONDARY outcome

Timeframe: Up to 23 weeks

Population: PK population Measure of dispersion is %CV

Cmax = maximum observed drug concentration during a dosing interval

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=43 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=42 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=44 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Cmax for Panitumumab - Part 2 Week 1	114 μg/mL Standard Deviation 27.7	124 μg/mL Standard Deviation 26.4	118 μg/mL Standard Deviation 34.7
Cmax for Panitumumab - Part 2 Week 3	149 μg/mL Standard Deviation 31.4	154 μg/mL Standard Deviation 29.0	139 μg/mL Standard Deviation 24.4
Cmax for Panitumumab - Part 2 Week 5	165 μg/mL Standard Deviation 30.1	172 μg/mL Standard Deviation 32.3	150 μg/mL Standard Deviation 26.5
Cmax for Panitumumab - Part 2 Week 7	166 μg/mL Standard Deviation 30.8	180 μg/mL Standard Deviation 29.6	167 μg/mL Standard Deviation 23.9
Cmax for Panitumumab - Part 2 Week 13	201 μg/mL Standard Deviation 26.7	199 μg/mL Standard Deviation 25.7	192 μg/mL Standard Deviation 31.2
Cmax for Panitumumab - Part 2 Week 23	196 μg/mL Standard Deviation 24.5	207 μg/mL Standard Deviation 24.9	187 μg/mL Standard Deviation 22.3

SECONDARY outcome

Timeframe: Up to 23 weeks

Population: PK population Measure of dispersion is %CV

Cmin = minimum drug concentration during a dosing interval

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=43 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Cmin for Rilotumumab - Part 2 Week 3	70.1 μg/mL Standard Deviation 41.2	—	—
Cmin for Rilotumumab - Part 2 Week 5	119 μg/mL Standard Deviation 31.8	—	—
Cmin for Rilotumumab - Part 2 Week 7	143 μg/mL Standard Deviation 27.5	—	—
Cmin for Rilotumumab - Part 2 Week 13	186 μg/mL Standard Deviation 40.7	—	—
Cmin for Rilotumumab - Part 2 Week 23	181 μg/mL Standard Deviation 36.3	—	—

SECONDARY outcome

Timeframe: Up to 23 weeks

Population: PK population Measure of dispersion is %CV

Cmax = maximum observed drug concentration during a dosing interval

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=43 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Cmax for Rilotumumab - Part 2 Week 1	239 μg/ml Standard Deviation 29.3	—	—
Cmax for Rilotumumab - Part 2 Week 3	316 μg/ml Standard Deviation 28.4	—	—
Cmax for Rilotumumab - Part 2 Week 5	357 μg/ml Standard Deviation 25.0	—	—
Cmax for Rilotumumab - Part 2 Week 7	397 μg/ml Standard Deviation 24.8	—	—
Cmax for Rilotumumab - Part 2 Week 13	453 μg/ml Standard Deviation 23.7	—	—
Cmax for Rilotumumab - Part 2 Week 23	421 μg/ml Standard Deviation 26.0	—	—

SECONDARY outcome

Timeframe: Up to 23 weeks

Population: PK population Measure of dispersion is %CV

Cmin = minimum drug concentration during a dosing interval

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=42 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Cmin for Ganitumab - Part 2 Week 3	19.8 μg/ml Standard Deviation 51.6	—	—
Cmin for Ganitumab - Part 2 Week 5	24.4 μg/ml Standard Deviation 55.2	—	—
Cmin for Ganitumab - Part 2 Week 7	28.9 μg/ml Standard Deviation 54.2	—	—
Cmin for Ganitumab - Part 2 Week 13	38.8 μg/ml Standard Deviation 61.6	—	—
Cmin for Ganitumab - Part 2 Week 23	39.7 μg/ml Standard Deviation 58.8	—	—

SECONDARY outcome

Timeframe: Up to 23 weeks

Population: PK population Measure of dispersion is %CV

Cmax = maximum observed drug concentration during a dosing interval

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=42 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Cmax for Ganitumab - Part 2 Week 1	218 μg/mL Standard Deviation 30.0	—	—
Cmax for Ganitumab - Part 2 Week 3	240 μg/mL Standard Deviation 25.3	—	—
Cmax for Ganitumab - Part 2 Week 5	244 μg/mL Standard Deviation 29.3	—	—
Cmax for Ganitumab - Part 2 Week 7	279 μg/mL Standard Deviation 35.5	—	—
Cmax for Ganitumab - Part 2 Week 13	274 μg/mL Standard Deviation 28.1	—	—
Cmax for Ganitumab - Part 2 Week 23	276 μg/mL Standard Deviation 22.8	—	—

SECONDARY outcome

Timeframe: First dose of any study drug and before 120 days of last dose of study drugs; up to 1 year, eight months

Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by either Biacore or ELISA.

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=46 Participants Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Total Anti-Panitumumab Antibody Incidence - Part 2	6.3 percentage of participants	18.8 percentage of participants	17.4 percentage of participants

SECONDARY outcome

Timeframe: First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.

Population: Only subjects having AMG-102 treatment in part 2 were measured for antibody incidence.

Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=48 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Total Anti-AMG 102 Antibody Incidence - Part 2	6.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: First dose of any study drug and before 120 days of last dose of study drugs, up to 1 year, eight months.

Population: Only subjects having AMG-479 treatment in part 2 were measured for antibody incidence.

Ratio of the number of subjects with at least one positive antibody result at baseline (or at any post-baseline or long-term follow-up time point) to the number of subjects with at least one immunoassay results at baseline (or at any post-baseline or long term follow-up time point). Measured by MSD.

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=46 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
Total Anti-AMG 479 Antibody Incidence - Part 2	17.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: 14 Days

Population: PK population

AUC = area under the drug concentration-time curve during a dosing interval

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=6 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
AUC for Rilotumumab	2300 day•μg/mL Interval 2020.0 to 3540.0	—	—

SECONDARY outcome

Timeframe: 14 Days

Population: PK Population

AUC = area under the drug concentration-time curve during a dosing interval

Outcome measures

Measure	Part 1: Panitumumab + Rilotumumab n=6 Participants Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.
AUC for Panitumumab	1200 day•μg/mL Interval 987.0 to 1890.0	—	—

Adverse Events

Part 1: Panitumumab + Rilotumumab

Serious events: 5 serious events

Other events: 11 other events

Deaths: 8 deaths

Part 2: Panitumumab Alone

Serious events: 11 serious events

Other events: 42 other events

Deaths: 32 deaths

Part 2: Panitumumab + Rilotumumab

Serious events: 9 serious events

Other events: 47 other events

Deaths: 35 deaths

Part 2: Panitumumab + Ganitumab

Serious events: 9 serious events

Other events: 44 other events

Deaths: 37 deaths

Part 3: Rilotumumab

Serious events: 6 serious events

Other events: 11 other events

Deaths: 8 deaths

Part 3: Ganitumab

Serious events: 2 serious events

Other events: 9 other events

Deaths: 8 deaths

Serious adverse events

Measure	Part 1: Panitumumab + Rilotumumab n=11 participants at risk Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab Alone n=48 participants at risk Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=48 participants at risk Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=46 participants at risk Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 3: Rilotumumab n=13 participants at risk Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.	Part 3: Ganitumab n=11 participants at risk Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
Blood and lymphatic system disorders Anaemia	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Cardiac disorders Arrhythmia supraventricular	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Ascites	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Constipation	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Diarrhoea	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Intestinal obstruction	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Fatigue	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders General physical health deterioration	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Pyrexia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Pneumonia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Sepsis	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Staphylococcal sepsis	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Eastern cooperative oncology group performance status worsened	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Cerebrovascular accident	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Loss of consciousness	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Renal and urinary disorders Renal failure acute	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Renal and urinary disorders Urinary retention	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Rash	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Vascular disorders Deep vein thrombosis	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Dermatitis acneiform	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Vascular disorders Capillary leak syndrome	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Disease progression	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Enterococcal infection	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Renal and urinary disorders Hydronephrosis	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Renal and urinary disorders Hypercreatininaemia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.

Other adverse events

Measure	Part 1: Panitumumab + Rilotumumab n=11 participants at risk Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab Alone n=48 participants at risk Participants received panitumumab 6 mg/kg and placebo by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Rilotumumab n=48 participants at risk Participants received panitumumab 6 mg/kg and rilotumumab 10 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 2: Panitumumab + Ganitumab n=46 participants at risk Participants received panitumumab 6 mg/kg and ganitumab 12 mg/kg by intravenous infusion once every 2 weeks until progressive disease, intolerability, withdrawal, death or sponsor decision.	Part 3: Rilotumumab n=13 participants at risk Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive rilotumumab 10 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.	Part 3: Ganitumab n=11 participants at risk Participants randomized to Panitumumab Alone in Part 2 who had disease progression (radiographic or clinical) or intolerability were re-randomized in Part 3 to receive ganitumab 12 mg/kg every 2 weeks until disease progression, intolerability, withdrawal, death, or sponsor decision.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pyogenic granuloma	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Dizziness	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Abdominal discomfort	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Anal inflammation	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Cheilitis	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Dyspepsia	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Dysphagia	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Gingival pain	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Peritoneal haemorrhage	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Face oedema	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Facial pain	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders General physical health deterioration	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Inflammation	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Hepatobiliary disorders Hepatic pain	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Immune system disorders Drug hypersensitivity	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Anogenital warts	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Candidiasis	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Pneumonia	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Skin bacterial infection	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Staphylococcal infection	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Vulvovaginal mycotic infection	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Injury, poisoning and procedural complications Contrast media reaction	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Injury, poisoning and procedural complications Eye injury	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Injury, poisoning and procedural complications Procedural vomiting	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Blood calcium decreased	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Blood magnesium decreased	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Blood potassium decreased	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Blood pressure increased	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Body temperature increased	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Breath sounds abnormal	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Platelet count decreased	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Dehydration	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hypercalcaemia	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Musculoskeletal and connective tissue disorders Myopathy	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Neuropathy peripheral	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Paraesthesia	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Polyneuropathy	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Renal and urinary disorders Oliguria	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Reproductive system and breast disorders Genital tract inflammation	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Hiccups	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Nasal congestion	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Nasal oedema	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Pharyngeal inflammation	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Eczema	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Hirsutism	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Ingrowing nail	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Koilonychia	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Skin oedema	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Vascular disorders Capillary leak syndrome	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Glucose tolerance impaired	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Alanine aminotransferase increased	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Blood alkaline phosphatase increased	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Immune system disorders Hypersensitivity	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Psychiatric disorders Confusional state	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Dysarthria	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Vascular disorders Flushing	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Endocrine disorders Glycosylated haemoglobin increased	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Endocrine disorders Hyperthyroidism	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Hyponatraemia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Infusion site inflammation	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Hepatobiliary disorders Jaundice	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Blood and lymphatic system disorders Leukopenia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Localised oedema	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Renal and urinary disorders Renal failure chronic	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Renal and urinary disorders Renal impairment	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Somnolence	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Tremor	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Blood and lymphatic system disorders Anaemia	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	14.6% 7/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	23.1% 3/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.5% 3/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Eye disorders Conjunctivitis	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	12.5% 6/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.5% 3/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Abdominal pain	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	14.6% 7/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.4% 5/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.5% 3/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Abdominal pain upper	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.4% 5/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Constipation	54.5% 6/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	22.9% 11/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.4% 5/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	13.0% 6/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	23.1% 3/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Diarrhoea	36.4% 4/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.4% 5/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	14.6% 7/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	23.9% 11/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Dry mouth	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.5% 3/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Gingival bleeding	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Nausea	36.4% 4/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	16.7% 8/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.5% 3/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	15.4% 2/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Stomatitis	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	13.0% 6/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Gastrointestinal disorders Vomiting	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	14.6% 7/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.9% 5/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Asthenia	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	14.6% 7/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	13.0% 6/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	45.5% 5/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Chills	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.5% 3/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Fatigue	36.4% 4/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	20.8% 10/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	17.4% 8/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Infusion related reaction	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.7% 4/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Mucosal inflammation	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	12.5% 6/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.9% 5/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Oedema peripheral	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	12.5% 6/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	18.8% 9/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	15.4% 2/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Pyrexia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Paronychia	36.4% 4/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	14.6% 7/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	31.2% 15/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	19.6% 9/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Aspartate aminotransferase increased	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Weight decreased	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.9% 5/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Investigations Weight increased	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Decreased appetite	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	16.7% 8/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	20.8% 10/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	19.6% 9/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	13.0% 6/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	15.4% 2/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hypocalcaemia	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hypokalaemia	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.4% 5/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	12.5% 6/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.7% 4/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Metabolism and nutrition disorders Hypomagnesaemia	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	20.8% 10/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	27.1% 13/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	41.3% 19/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Musculoskeletal and connective tissue disorders Back pain	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Musculoskeletal and connective tissue disorders Muscle spasms	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.7% 4/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Headache	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	12.5% 6/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Nervous system disorders Lethargy	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Psychiatric disorders Anxiety	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Psychiatric disorders Depression	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	15.4% 2/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Psychiatric disorders Insomnia	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.4% 5/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.4% 5/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.7% 4/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnoea	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.5% 3/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	14.6% 7/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Acne	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.9% 5/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Dermatitis acneiform	54.5% 6/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	33.3% 16/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	35.4% 17/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	26.1% 12/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Dry skin	36.4% 4/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	14.6% 7/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	22.9% 11/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	21.7% 10/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Erythema	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	8.3% 4/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	10.9% 5/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Nail disorder	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	6.2% 3/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Pruritus	45.5% 5/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	25.0% 12/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	20.8% 10/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	28.3% 13/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Rash	36.4% 4/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	52.1% 25/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	58.3% 28/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	47.8% 22/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	23.1% 3/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Skin fissures	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	16.7% 8/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	14.6% 7/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	26.1% 12/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Eye disorders Dry eye	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
General disorders Oedema	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Infection	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Infections and infestations Urinary tract infection	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Cough	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Dermatitis	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Hypertrichosis	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Skin and subcutaneous tissue disorders Pain of skin	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.2% 1/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Vascular disorders Hypertension	27.3% 3/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.2% 2/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	7.7% 1/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Cardiac disorders Tachycardia	18.2% 2/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Ear and labyrinth disorders Ear pain	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Ear and labyrinth disorders Hypoacusis	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Ear and labyrinth disorders Otorrhoea	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Ear and labyrinth disorders Tinnitus	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Eye disorders Eye irritation	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	2.1% 1/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	4.3% 2/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.
Eye disorders Keratitis	9.1% 1/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/48 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/46 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/13 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.	0.00% 0/11 • All non-serious AEs that occurred after initiation of investigational product through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks. All serious AEs that occurred after the subject signed the informed consent form through 30 days after the last dose of investigational product or the 30-day safety follow-up visit, whichever was later, up to 56 weeks.

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: Bobby.Reddy@Immunitybio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place