Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly (NCT NCT00994214)

NCT ID: NCT00994214

Last Updated: 2019-11-22

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

109 participants

Primary outcome timeframe

At Month 6

Results posted on

2019-11-22

Participant Flow

This was a multicentre study conducted at 36 investigational sites in 16 countries: Czech Republic, Lithuania, Poland, Romania, Ukraine, Latvia, USA, United Kingdom (UK), Italy, Mexico, Brazil, France, Belgium, Netherlands, Germany and Sweden.

Screened subjects were 109 and screen failures were 33. Subjects randomised and treated in part A were 76. Subjects completed part A were 21 and subjects entered Part B were 12, excluding 9 subjects, who chose not to continue in part B. No subjects completed the study.

Participant milestones

Participant milestones
Measure	Arm A: BIM 23A760 1 mg BIM 23A760 1 mg subcutaneous 24 weekly injections.	Arm B: BIM 23A760 2 mg BIM 23A760 2 mg subcutaneous 24 weekly injections.	Arm C: BIM 23A760 4 mg BIM 23A760 4 mg subcutaneous 24 weekly injections.	Arm D: BIM 23A760 6 mg BIM 23A760 6 mg subcutaneous 24 weekly injections.
ITT (Intention-to-Treat) - Part A STARTED	19	19	18	20
ITT (Intention-to-Treat) - Part A COMPLETED	5	6	5	5
ITT (Intention-to-Treat) - Part A NOT COMPLETED	14	13	13	15
ITT (Intention-to-Treat) - Part B STARTED	4	3	2	3
ITT (Intention-to-Treat) - Part B Received Maximum Dose of 1mg	0	0	0	0
ITT (Intention-to-Treat) - Part B Received Maximum Dose of 2mg	3	0	0	0
ITT (Intention-to-Treat) - Part B Received Maximum Dose of 4mg	1	3	0	0
ITT (Intention-to-Treat) - Part B Received Maximum Dose of 6mg	0	0	2	3
ITT (Intention-to-Treat) - Part B COMPLETED	0	0	0	0
ITT (Intention-to-Treat) - Part B NOT COMPLETED	4	3	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: BIM 23A760 1 mg BIM 23A760 1 mg subcutaneous 24 weekly injections.	Arm B: BIM 23A760 2 mg BIM 23A760 2 mg subcutaneous 24 weekly injections.	Arm C: BIM 23A760 4 mg BIM 23A760 4 mg subcutaneous 24 weekly injections.	Arm D: BIM 23A760 6 mg BIM 23A760 6 mg subcutaneous 24 weekly injections.
ITT (Intention-to-Treat) - Part A Adverse Event	0	1	0	0
ITT (Intention-to-Treat) - Part A Withdrawal by Subject	0	0	0	1
ITT (Intention-to-Treat) - Part A Lost to Follow-up	1	0	0	0
ITT (Intention-to-Treat) - Part A Withdrawn - Study termination by sponsor	13	12	13	14
ITT (Intention-to-Treat) - Part B Withdrawal by Subject	0	0	0	1
ITT (Intention-to-Treat) - Part B Withdrawn - Study termination by sponsor	4	3	2	2

Baseline Characteristics

Study to Assess the Efficacy and Safety of Repeated Administration of BIM 23A760 in Patients With Acromegaly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: BIM 23A760 1 mg n=19 Participants BIM 23A760 1 mg subcutaneous 24 weekly injections.	Arm B: BIM 23A760 2 mg n=19 Participants BIM 23A760 2 mg subcutaneous 24 weekly injections.	Arm C: BIM 23A760 4 mg n=18 Participants BIM 23A760 4 mg subcutaneous 24 weekly injections.	Arm D: BIM 23A760 6 mg n=20 Participants BIM 23A760 6 mg subcutaneous 24 weekly injections..	Total n=76 Participants Total of all reporting groups
Age, Continuous	42.8 Years STANDARD_DEVIATION 11.3 • n=99 Participants	48.7 Years STANDARD_DEVIATION 11.2 • n=107 Participants	40.3 Years STANDARD_DEVIATION 11.3 • n=206 Participants	43.4 Years STANDARD_DEVIATION 12.9 • n=7 Participants	43.8 Years STANDARD_DEVIATION 11.9 • n=31 Participants
Sex: Female, Male Female	10 Participants n=99 Participants	13 Participants n=107 Participants	6 Participants n=206 Participants	13 Participants n=7 Participants	42 Participants n=31 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	6 Participants n=107 Participants	12 Participants n=206 Participants	7 Participants n=7 Participants	34 Participants n=31 Participants
Race/Ethnicity, Customized Caucasian/White	17 Participants n=99 Participants	14 Participants n=107 Participants	13 Participants n=206 Participants	18 Participants n=7 Participants	62 Participants n=31 Participants
Race/Ethnicity, Customized Multiple race	2 Participants n=99 Participants	5 Participants n=107 Participants	5 Participants n=206 Participants	2 Participants n=7 Participants	14 Participants n=31 Participants
Region of Enrollment Belgium	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	2 Participants n=31 Participants
Region of Enrollment Brazil	1 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants	10 Participants n=31 Participants
Region of Enrollment Czech Republic	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	3 Participants n=31 Participants
Region of Enrollment Lithuania	1 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants	1 Participants n=7 Participants	6 Participants n=31 Participants
Region of Enrollment Mexico	2 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants	1 Participants n=7 Participants	11 Participants n=31 Participants
Region of Enrollment Netherlands	2 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	3 Participants n=31 Participants
Region of Enrollment Poland	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	2 Participants n=31 Participants
Region of Enrollment Romania	4 Participants n=99 Participants	3 Participants n=107 Participants	1 Participants n=206 Participants	4 Participants n=7 Participants	12 Participants n=31 Participants
Region of Enrollment Ukraine	6 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants	6 Participants n=7 Participants	20 Participants n=31 Participants
Region of Enrollment France	0 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	1 Participants n=7 Participants	2 Participants n=31 Participants
Region of Enrollment United States	0 Participants n=99 Participants	2 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	3 Participants n=31 Participants
Region of Enrollment Latvia	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Region of Enrollment Sweden	0 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants	0 Participants n=7 Participants	1 Participants n=31 Participants
Height	170.1 cm STANDARD_DEVIATION 8.1 • n=99 Participants	170.3 cm STANDARD_DEVIATION 13.2 • n=107 Participants	175.0 cm STANDARD_DEVIATION 10.1 • n=206 Participants	166.4 cm STANDARD_DEVIATION 8.6 • n=7 Participants	170.3 cm STANDARD_DEVIATION 10.4 • n=31 Participants
Diabetic status at entry Diabetic	2 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants	2 Participants n=7 Participants	7 Participants n=31 Participants
Diabetic status at entry Non-diabetic	17 Participants n=99 Participants	18 Participants n=107 Participants	16 Participants n=206 Participants	18 Participants n=7 Participants	69 Participants n=31 Participants
Insulin-like growth factor 1 (IGF-1)	307 Percentage of ULN(Upper limit of number) n=99 Participants	315 Percentage of ULN(Upper limit of number) n=107 Participants	382 Percentage of ULN(Upper limit of number) n=206 Participants	335 Percentage of ULN(Upper limit of number) n=7 Participants	333 Percentage of ULN(Upper limit of number) n=31 Participants
Growth Hormone (GH)	16.79 ng/mL STANDARD_DEVIATION 24.56 • n=99 Participants	20.99 ng/mL STANDARD_DEVIATION 59.28 • n=107 Participants	28.60 ng/mL STANDARD_DEVIATION 64.83 • n=206 Participants	26.59 ng/mL STANDARD_DEVIATION 63.47 • n=7 Participants	23.21 ng/mL STANDARD_DEVIATION 55.54 • n=31 Participants
Baseline Prolactin Males (n=A:9,B:6,C:12, D:7, and Total:34)	11.506 μg/L STANDARD_DEVIATION 14.233 • n=99 Participants	34.113 μg/L STANDARD_DEVIATION 49.588 • n=107 Participants	41.657 μg/L STANDARD_DEVIATION 60.965 • n=206 Participants	83.036 μg/L STANDARD_DEVIATION 131.024 • n=7 Participants	40.86 μg/L STANDARD_DEVIATION 72.52 • n=31 Participants
Baseline Prolactin Pre-menopausal female(n=A:4,B:4,C:4,D:7,&Totl:19)	19.838 μg/L STANDARD_DEVIATION 15.247 • n=99 Participants	26.158 μg/L STANDARD_DEVIATION 19.798 • n=107 Participants	35.608 μg/L STANDARD_DEVIATION 25.536 • n=206 Participants	23.634 μg/L STANDARD_DEVIATION 23.778 • n=7 Participants	25.88 μg/L STANDARD_DEVIATION 21.94 • n=31 Participants
Baseline Prolactin Post-menopausal female(n=A:6,B:9,C:2,D:6,&Totl:23)	8.420 μg/L STANDARD_DEVIATION 3.167 • n=99 Participants	16.409 μg/L STANDARD_DEVIATION 24.232 • n=107 Participants	7.870 μg/L STANDARD_DEVIATION 0.693 • n=206 Participants	25.118 μg/L STANDARD_DEVIATION 39.986 • n=7 Participants	15.85 μg/L STANDARD_DEVIATION 25.89 • n=31 Participants
Ring Finger Circumference	70.2 mm STANDARD_DEVIATION 5.6 • n=99 Participants	68.5 mm STANDARD_DEVIATION 6.2 • n=107 Participants	71.2 mm STANDARD_DEVIATION 4.7 • n=206 Participants	68.4 mm STANDARD_DEVIATION 6.3 • n=7 Participants	69.53 mm STANDARD_DEVIATION 5.75 • n=31 Participants

PRIMARY outcome

Timeframe: At Month 6

Population: Intention-to-Treat (ITT) population: All randomized subjects who received at least one dose of study medication. N=Number of subjects attended Month 6 (visit 9).

Outcome measures

Outcome measures
Measure	Arm A: BIM 23A760 1 mg n=6 Participants BIM 23A760 1 mg subcutaneous 24 weekly injections.	Arm B: BIM 23A760 2 mg n=7 Participants BIM 23A760 2 mg subcutaneous 24 weekly injections.	Arm C: BIM 23A760 4 mg n=5 Participants BIM 23A760 4 mg subcutaneous 24 weekly injections.	Arm D: BIM 23A760 6 mg n=5 Participants BIM 23A760 6 mg subcutaneous 24 weekly injections.	Overall - Part A	Part B: Arm B: BIM 23A760 2 mg	Part B: Arm C: BIM 23A760 4 mg	Part B: Arm D: BIM 23A760 6 mg	Overall - Part B
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	—	—	—	—	—
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 Mean GH ≤2.5 ng/mL and Normalised IGF-1: No	83.3 Percentage of subjects	100.0 Percentage of subjects	100.0 Percentage of subjects	100.0 Percentage of subjects	—	—	—	—	—
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 Missing	16.7 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 3

Population: ITT population. N=Number of subjects attended Month 3 (visit 7).

Outcome measures

Outcome measures
Measure	Arm A: BIM 23A760 1 mg n=12 Participants BIM 23A760 1 mg subcutaneous 24 weekly injections.	Arm B: BIM 23A760 2 mg n=13 Participants BIM 23A760 2 mg subcutaneous 24 weekly injections.	Arm C: BIM 23A760 4 mg n=12 Participants BIM 23A760 4 mg subcutaneous 24 weekly injections.	Arm D: BIM 23A760 6 mg n=13 Participants BIM 23A760 6 mg subcutaneous 24 weekly injections.	Overall - Part A	Part B: Arm B: BIM 23A760 2 mg	Part B: Arm C: BIM 23A760 4 mg	Part B: Arm D: BIM 23A760 6 mg	Overall - Part B
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 Missing	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	—	—	—	—	—
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	7.7 Percentage of subjects	—	—	—	—	—
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 Mean GH ≤2.5 ng/mL and Normalised IGF-1: No	100 Percentage of subjects	100 Percentage of subjects	100 Percentage of subjects	92.3 Percentage of subjects	—	—	—	—	—

SECONDARY outcome

Timeframe: At Month 1

Population: ITT population. N=Number of subjects attended Month 1 (visit 5).

Outcome measures

Outcome measures
Measure	Arm A: BIM 23A760 1 mg n=19 Participants BIM 23A760 1 mg subcutaneous 24 weekly injections.	Arm B: BIM 23A760 2 mg n=18 Participants BIM 23A760 2 mg subcutaneous 24 weekly injections.	Arm C: BIM 23A760 4 mg n=18 Participants BIM 23A760 4 mg subcutaneous 24 weekly injections.	Arm D: BIM 23A760 6 mg n=20 Participants BIM 23A760 6 mg subcutaneous 24 weekly injections.	Overall - Part A	Part B: Arm B: BIM 23A760 2 mg	Part B: Arm C: BIM 23A760 4 mg	Part B: Arm D: BIM 23A760 6 mg	Overall - Part B
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 Mean GH ≤2.5 ng/mL and Normalised IGF-1: Yes	5.3 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	5.0 Percentage of subjects	—	—	—	—	—
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 Mean GH ≤2.5 ng/mL and Normalised IGF-1: No	94.7 Percentage of subjects	100 Percentage of subjects	100 Percentage of subjects	95.0 Percentage of subjects	—	—	—	—	—
Percentage of Subjects With Mean GH ≤2.5 ng/mL and Normalised IGF-1 Missing	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	0 Percentage of subjects	—	—	—	—	—

SECONDARY outcome

Timeframe: 0-3 hr on Baseline (Day 1) and Months 1, 3 and 6

Population: N=Number of patients randomised to treatment in IGF-1 \<2.5 x upper limit of normal (ULN) stratum and IGF-1 ≥2.5 x ULN stratum.

Percentage change from Baseline at month X = (Mean GH at month X - Mean GH at baseline) x 100 / Mean GH at baseline

Outcome measures

Outcome measures
Measure	Arm A: BIM 23A760 1 mg n=15 Participants BIM 23A760 1 mg subcutaneous 24 weekly injections.	Arm B: BIM 23A760 2 mg n=15 Participants BIM 23A760 2 mg subcutaneous 24 weekly injections.	Arm C: BIM 23A760 4 mg n=15 Participants BIM 23A760 4 mg subcutaneous 24 weekly injections.	Arm D: BIM 23A760 6 mg n=16 Participants BIM 23A760 6 mg subcutaneous 24 weekly injections.	Overall - Part A	Part B: Arm B: BIM 23A760 2 mg	Part B: Arm C: BIM 23A760 4 mg	Part B: Arm D: BIM 23A760 6 mg	Overall - Part B
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 At Month 3: IGF-1<2.5 x ULN	29.26 Percentage of change in mean GH Standard Deviation 45.97	-18.99 Percentage of change in mean GH Standard Deviation 21.36	17.48 Percentage of change in mean GH Standard Deviation 127.97	-28.84 Percentage of change in mean GH Standard Deviation 43.25	—	—	—	—	—
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 At Month 6: IGF-1≥2.5 x UL	-36.15 Percentage of change in mean GH Standard Deviation 45.63	15.28 Percentage of change in mean GH Standard Deviation 82.56	-10.43 Percentage of change in mean GH Standard Deviation 28.90	-19.47 Percentage of change in mean GH Standard Deviation 68.90	—	—	—	—	—
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 At Month 1: IGF-1<2.5 x ULN	4.10 Percentage of change in mean GH Standard Deviation 53.03	-0.55 Percentage of change in mean GH Standard Deviation 23.98	-9.92 Percentage of change in mean GH Standard Deviation 71.51	-17.59 Percentage of change in mean GH Standard Deviation 41.82	—	—	—	—	—
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 At Month 6: IGF-1<2.5 x ULN	71.44 Percentage of change in mean GH Standard Deviation 35.97	3.32 Percentage of change in mean GH Standard Deviation 9.09	82.45 Percentage of change in mean GH Standard Deviation 0	-38.21 Percentage of change in mean GH Standard Deviation 27.27	—	—	—	—	—
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 At Month 1: IGF-1≥2.5 x UL	-39.20 Percentage of change in mean GH Standard Deviation 30.33	-22.24 Percentage of change in mean GH Standard Deviation 34.72	-10.64 Percentage of change in mean GH Standard Deviation 51.18	-23.63 Percentage of change in mean GH Standard Deviation 39.57	—	—	—	—	—
Percent Change From Baseline in the Mean GH From 0-3 Hours at Months 1, 3 and 6 At Month 3: IGF-1≥2.5 x UL	-26.14 Percentage of change in mean GH Standard Deviation 39.60	-22.35 Percentage of change in mean GH Standard Deviation 31.71	-7.64 Percentage of change in mean GH Standard Deviation 30.11	-20.53 Percentage of change in mean GH Standard Deviation 42.23	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Month 6

Population: ITT population

Outcome measures

Outcome measures
Measure	Arm A: BIM 23A760 1 mg n=19 Participants BIM 23A760 1 mg subcutaneous 24 weekly injections.	Arm B: BIM 23A760 2 mg n=19 Participants BIM 23A760 2 mg subcutaneous 24 weekly injections.	Arm C: BIM 23A760 4 mg n=18 Participants BIM 23A760 4 mg subcutaneous 24 weekly injections.	Arm D: BIM 23A760 6 mg n=20 Participants BIM 23A760 6 mg subcutaneous 24 weekly injections.	Overall - Part A	Part B: Arm B: BIM 23A760 2 mg	Part B: Arm C: BIM 23A760 4 mg	Part B: Arm D: BIM 23A760 6 mg	Overall - Part B
Changes in IGF-1	-51.30 Percentage of ULN Standard Deviation 136.66	-53.31 Percentage of ULN Standard Deviation 80.57	-40.53 Percentage of ULN Standard Deviation 56.65	-85.91 Percentage of ULN Standard Deviation 95.34	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Month 6

Population: ITT population. N=Number of subjects attended Month 6 (visit 9).

Percentage change from Baseline at month X = (Ring finger circumference at month X - ring finger circumference at baseline) x 100 / ring finger circumference at baseline.

Outcome measures

Outcome measures
Measure	Arm A: BIM 23A760 1 mg n=6 Participants BIM 23A760 1 mg subcutaneous 24 weekly injections.	Arm B: BIM 23A760 2 mg n=7 Participants BIM 23A760 2 mg subcutaneous 24 weekly injections.	Arm C: BIM 23A760 4 mg n=5 Participants BIM 23A760 4 mg subcutaneous 24 weekly injections.	Arm D: BIM 23A760 6 mg n=5 Participants BIM 23A760 6 mg subcutaneous 24 weekly injections.	Overall - Part A	Part B: Arm B: BIM 23A760 2 mg	Part B: Arm C: BIM 23A760 4 mg	Part B: Arm D: BIM 23A760 6 mg	Overall - Part B
Percentage Change in Ring Finger Circumference	-3.518 Percentage of Change in Ring Finger circ Standard Deviation 3.688	-1.469 Percentage of Change in Ring Finger circ Standard Deviation 2.120	-0.678 Percentage of Change in Ring Finger circ Standard Deviation 2.409	-4.003 Percentage of Change in Ring Finger circ Standard Deviation 3.367	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to Visit 10 (An average of 6.5 Months)

Population: Safety Population Part B: Arm A: BIM 23A760 1 mg- 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.

For summaries of intensity and causality, individual patients may be reported in more than one category. In the event of multiple episodes of AEs being reported by the same patient during the study, the maximum intensity (severe \> moderate \> mild) and the most serious causality (related \> not related) have been chosen. TEAE (Treatment emergent adverse event) are reported by Maximum Dose Received in Each Part of the Study.

Outcome measures

Outcome measures
Measure	Arm A: BIM 23A760 1 mg n=19 Participants BIM 23A760 1 mg subcutaneous 24 weekly injections.	Arm B: BIM 23A760 2 mg n=19 Participants BIM 23A760 2 mg subcutaneous 24 weekly injections.	Arm C: BIM 23A760 4 mg n=18 Participants BIM 23A760 4 mg subcutaneous 24 weekly injections.	Arm D: BIM 23A760 6 mg n=20 Participants BIM 23A760 6 mg subcutaneous 24 weekly injections.	Overall - Part A n=76 Participants	Part B: Arm B: BIM 23A760 2 mg n=3 Participants	Part B: Arm C: BIM 23A760 4 mg n=4 Participants	Part B: Arm D: BIM 23A760 6 mg n=5 Participants	Overall - Part B n=12 Participants
Number of Subjects Reported Adverse Events During the Study Severe	0 Participants	1 Participants	1 Participants	2 Participants	4 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reported Adverse Events During the Study Moderate	3 Participants	8 Participants	4 Participants	7 Participants	22 Participants	0 Participants	0 Participants	3 Participants	3 Participants
Number of Subjects Reported Adverse Events During the Study Mild	11 Participants	9 Participants	12 Participants	15 Participants	47 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects Reported Adverse Events During the Study Related	7 Participants	8 Participants	10 Participants	11 Participants	36 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects Reported Adverse Events During the Study Not Related	8 Participants	9 Participants	6 Participants	11 Participants	34 Participants	0 Participants	1 Participants	3 Participants	4 Participants

Adverse Events

Part A: Arm A: BIM 23A760 1 mg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Part A: Arm B: BIM 23A760 2 mg

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Part A: Arm C: BIM 23A760 4 mg

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part A: Arm D: BIM 23A760 6 mg

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Overall - Part A

Serious events: 3 serious events

Other events: 50 other events

Deaths: 0 deaths

Part B: Arm B: BIM 23A760 2 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part B: Arm C: BIM 23A760 4 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Arm D: BIM 23A760 6 mg

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Overall - Part B

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Arm A: BIM 23A760 1 mg n=19 participants at risk	Part A: Arm B: BIM 23A760 2 mg n=19 participants at risk	Part A: Arm C: BIM 23A760 4 mg n=18 participants at risk	Part A: Arm D: BIM 23A760 6 mg n=20 participants at risk	Overall - Part A n=76 participants at risk	Part B: Arm B: BIM 23A760 2 mg n=3 participants at risk	Part B: Arm C: BIM 23A760 4 mg n=4 participants at risk	Part B: Arm D: BIM 23A760 6 mg n=5 participants at risk	Overall - Part B n=12 participants at risk
Gastrointestinal disorders Gastritis	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/76 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	20.0% 1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	8.3% 1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Ear and labyrinth disorders Vertigo	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders Nausea	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Infections and infestations Sinusitis	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/76 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	20.0% 1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	8.3% 1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.

Other adverse events

Other adverse events
Measure	Part A: Arm A: BIM 23A760 1 mg n=19 participants at risk	Part A: Arm B: BIM 23A760 2 mg n=19 participants at risk	Part A: Arm C: BIM 23A760 4 mg n=18 participants at risk	Part A: Arm D: BIM 23A760 6 mg n=20 participants at risk	Overall - Part A n=76 participants at risk	Part B: Arm B: BIM 23A760 2 mg n=3 participants at risk	Part B: Arm C: BIM 23A760 4 mg n=4 participants at risk	Part B: Arm D: BIM 23A760 6 mg n=5 participants at risk	Overall - Part B n=12 participants at risk
Nervous system disorders HEADACHE	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	15.0% 3/20 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 4/76 • Number of events 6 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Blood and lymphatic system disorders ANAEMIA	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.0% 2/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	3.9% 3/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Ear and labyrinth disorders VERTIGO	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Eye disorders EYE IRRITATION	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Eye disorders LACRIMATION INCREASED	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders ABDOMINAL PAIN	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	15.0% 3/20 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	7.9% 6/76 • Number of events 9 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders CONSTIPATION	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.0% 2/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 4/76 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders DIARRHOEA	10.5% 2/19 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 10 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.0% 2/20 • Number of events 7 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	7.9% 6/76 • Number of events 21 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders FLATULENCE	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	11.1% 2/18 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	6.6% 5/76 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders GASTROINTESTINAL PAIN	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders NAUSEA	10.5% 2/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.5% 2/19 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	11.1% 2/18 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.0% 2/20 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.5% 8/76 • Number of events 13 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders PROCTALGIA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders VOMITING	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	3.9% 3/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders ADMINISTRATION SITE REACTION	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 7 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 7 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders APPLICATION SITE ERYTHEMA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders APPLICATION SITE INDURATION	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders ASTHENIA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders FATIGUE	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders HYPERTHERMIA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders INJECTION SITE ERYTHEMA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.5% 2/19 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 15 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	15.0% 3/20 • Number of events 10 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	7.9% 6/76 • Number of events 29 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders INJECTION SITE INDURATION	10.5% 2/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.5% 2/19 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	22.2% 4/18 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	11.8% 9/76 • Number of events 13 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders INJECTION SITE INFLAMMATION	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders INJECTION SITE NODULE	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	11.1% 2/18 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.0% 2/20 • Number of events 6 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	7.9% 6/76 • Number of events 12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders INJECTION SITE PAIN	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	11.1% 2/18 • Number of events 6 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.0% 2/20 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 4/76 • Number of events 11 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders INJECTION SITE PRURITUS	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.5% 2/19 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	16.7% 3/18 • Number of events 16 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	15.0% 3/20 • Number of events 7 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.5% 8/76 • Number of events 27 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders INJECTION SITE RASH	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders INJECTION SITE REACTION	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.5% 2/19 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.0% 2/20 • Number of events 9 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 4/76 • Number of events 13 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders INJECTION SITE SWELLING	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
General disorders OEDEMA PERIPHERAL	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Infections and infestations CYSTITIS	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Infections and infestations FUNGAL SKIN INFECTION	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Infections and infestations NASOPHARYNGITIS	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	3.9% 3/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Infections and infestations SINUSITIS	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	20.0% 1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	8.3% 1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Injury, poisoning and procedural complications CONCUSSION	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Injury, poisoning and procedural complications WOUND	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.5% 2/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	10.5% 2/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations BLOOD AMYLASE INCREASED	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations BLOOD PRESSURE DECREASED	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	11.1% 2/18 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations BLOOD PRESSURE DIASTOLIC INCREASED	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations BLOOD THYROID STIMULATING HORMONE DECREASED	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations RED BLOOD CELLS URINE POSITIVE	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations TRI-IODOTHYRONINE FREE INCREASED	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations WHITE BLOOD CELL COUNT DECREASED	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations WHITE BLOOD CELLS URINE POSITIVE	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Metabolism and nutrition disorders HYPERGLYCAEMIA	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Metabolism and nutrition disorders IMPAIRED FASTING GLUCOSE	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Musculoskeletal and connective tissue disorders SYNOVITIS	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Nervous system disorders ACOUSTIC NEURITIS	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Nervous system disorders CARPAL TUNNEL SYNDROME	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Nervous system disorders DIZZINESS	10.5% 2/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	6.6% 5/76 • Number of events 6 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Nervous system disorders HYPOAESTHESIA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Nervous system disorders PARAESTHESIA	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Nervous system disorders PRESYNCOPE	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Nervous system disorders SYNCOPE	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Nervous system disorders TRIGEMINAL NEURALGIA	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Psychiatric disorders INSOMNIA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Renal and urinary disorders POLLAKIURIA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Reproductive system and breast disorders MENSTRUATION DELAYED	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISORDER	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Skin and subcutaneous tissue disorders HYPERKERATOSIS	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Skin and subcutaneous tissue disorders PRURITUS	5.3% 1/19 • Number of events 2 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.0% 1/20 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	2.6% 2/76 • Number of events 3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Vascular disorders HYPOTENSION	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	16.7% 3/18 • Number of events 4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.3% 4/76 • Number of events 5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Vascular disorders PERIPHERAL COLDNESS	5.3% 1/19 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Vascular disorders PHLEBITIS	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	5.6% 1/18 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	1.3% 1/76 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/12 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Gastrointestinal disorders GASTRITIS	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/76 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	20.0% 1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	8.3% 1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Hepatobiliary disorders CHOLELITHIASIS	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/76 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	20.0% 1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	8.3% 1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Hepatobiliary disorders CYTOLYTIC HEPATITIS	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/76 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	25.0% 1/4 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/5 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	8.3% 1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.
Investigations BLOOD PRESSURE INCREASED	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/19 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/18 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/20 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/76 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/3 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	0.00% 0/4 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	20.0% 1/5 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.	8.3% 1/12 • Number of events 1 • Up to Visit 10 (An average of 6.5 Months) Included Serious Adverse Events (SAEs) and Adverse Events (AEs) during treatment phase for Safety Population TEAE are reported by Maximum Dose Received in Each Part of the Study. 4 subjects from part B, Arm A were considered under other arms of part B based on the maximum dose received.

Additional Information

Medical Director, Endocrinology

Ipsen

Phone: [email protected]

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place