Trial Outcomes & Findings for Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis. (NCT NCT03275064)

Last Updated: 2024-10-09

Results Overview

Collagen fibril organization in articular cartilage evaluated by Magnetic Resonance Imaging (MRI) from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the focal cartilage lesion.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

142 participants

Primary outcome timeframe

Baseline up to Week 16, Week 28

Results posted on

2024-10-09

Participant Flow

A total of 142 participants were randomized, but only 141 received treatment. One participant in Part B was discontinued due to poor veins that were not adequate for blood samples.

Participant milestones

Participant milestones
Measure	LNA043 20 mg Part A Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	LNA043 20 mg Part B Part B: a single intra-articular injection of 20 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	LNA043 40 mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis
Treatment Period Part A and Part B STARTED	43	15	27	27	29
Treatment Period Part A and Part B COMPLETED	42	15	27	26	29
Treatment Period Part A and Part B NOT COMPLETED	1	0	0	1	0
Post-treatment Follow-up Parts A and B STARTED	41	15	27	26	29
Post-treatment Follow-up Parts A and B COMPLETED	39	15	24	25	28
Post-treatment Follow-up Parts A and B NOT COMPLETED	2	0	3	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	LNA043 20 mg Part A Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	LNA043 20 mg Part B Part B: a single intra-articular injection of 20 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	LNA043 40 mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis
Treatment Period Part A and Part B PI decision based on poor veins for blood sampling	0	0	1	0
Treatment Period Part A and Part B Patient discontinued treatment and entered follow-up	1	0	0	0
Post-treatment Follow-up Parts A and B Lost to Follow-up	1	2	0	1
Post-treatment Follow-up Parts A and B No longer required treatment	0	0	1	0
Post-treatment Follow-up Parts A and B Subject/guardian decision	1	1	0	0

Baseline Characteristics

Category breakdown for age differed for Part A and Part B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LNA043 20 mg Part A n=43 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=15 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	LNA043 20 mg Part B n=27 Participants Part B: a single intra-articular injection of 20 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	LNA043 40 mg Part B n=27 Participants Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B n=29 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	Total n=141 Participants Total of all reporting groups
Age, Customized ≥18 and ≤55 years Part A only	43 participants n=43 Participants • Category breakdown for age differed for Part A and Part B	15 participants n=15 Participants • Category breakdown for age differed for Part A and Part B	—	—	—	58 participants n=58 Participants • Category breakdown for age differed for Part A and Part B
Age, Customized ≥18 and ≤64 Part B only	—	—	18 participants n=27 Participants • Category breakdown for age differed for Part A and Part B	15 participants n=27 Participants • Category breakdown for age differed for Part A and Part B	15 participants n=29 Participants • Category breakdown for age differed for Part A and Part B	48 participants n=83 Participants • Category breakdown for age differed for Part A and Part B
Age, Customized ≥65 and ≤76 years - Part B only	—	—	9 participants n=27 Participants • Category breakdown for age differed for Part A and Part B	12 participants n=27 Participants • Category breakdown for age differed for Part A and Part B	14 participants n=29 Participants • Category breakdown for age differed for Part A and Part B	35 participants n=83 Participants • Category breakdown for age differed for Part A and Part B
Sex: Female, Male Female	21 Participants n=43 Participants	5 Participants n=15 Participants	19 Participants n=27 Participants	20 Participants n=27 Participants	21 Participants n=29 Participants	86 Participants n=141 Participants
Sex: Female, Male Male	22 Participants n=43 Participants	10 Participants n=15 Participants	8 Participants n=27 Participants	7 Participants n=27 Participants	8 Participants n=29 Participants	55 Participants n=141 Participants
Race/Ethnicity, Customized Asian	1 participants n=43 Participants	1 participants n=15 Participants	0 participants n=27 Participants	0 participants n=27 Participants	1 participants n=29 Participants	3 participants n=141 Participants
Race/Ethnicity, Customized White	42 participants n=43 Participants	11 participants n=15 Participants	20 participants n=27 Participants	26 participants n=27 Participants	24 participants n=29 Participants	123 participants n=141 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=43 Participants	1 participants n=15 Participants	0 participants n=27 Participants	0 participants n=27 Participants	0 participants n=29 Participants	1 participants n=141 Participants
Race/Ethnicity, Customized Black or African	0 participants n=43 Participants	1 participants n=15 Participants	7 participants n=27 Participants	1 participants n=27 Participants	3 participants n=29 Participants	12 participants n=141 Participants
Race/Ethnicity, Customized American Unknow	0 participants n=43 Participants	1 participants n=15 Participants	0 participants n=27 Participants	0 participants n=27 Participants	0 participants n=29 Participants	1 participants n=141 Participants
Race/Ethnicity, Customized Other	0 participants n=43 Participants	0 participants n=15 Participants	0 participants n=27 Participants	0 participants n=27 Participants	1 participants n=29 Participants	1 participants n=141 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 16, Week 28

Population: Pharmacodynamic (PD) analysis set: Subjects with available PD data

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=43 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=15 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Change From Baseline in Articular Cartilage Collagen Organization in the Overall Cartilage (Femoral and Patellar Lesions) - Part A Week 16 n=43,14	3.28 ms Standard Error 9.78	2.79 ms Standard Error 16.37	—	—	—
Change From Baseline in Articular Cartilage Collagen Organization in the Overall Cartilage (Femoral and Patellar Lesions) - Part A Week 28 n=39,15	5.66 ms Standard Error 9.90	1.98 ms Standard Error 15.97	—	—	—

PRIMARY outcome

Timeframe: Baseline up to Week 16, Week 28

Population: Pharmacodynamic (PD) analysis set: Subjects with available PD data

Collagen fibril organization in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the focal cartilage lesion.

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=41 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=15 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Change From Baseline in Articular Cartilage Collagen Organization in the Deep Cartilage Layer (Femoral and Patellar Lesions) - Part A Week 28 n=39,15	7.86 ms Standard Error 9.36	1.90 ms Standard Error 15.08	—	—	—
Change From Baseline in Articular Cartilage Collagen Organization in the Deep Cartilage Layer (Femoral and Patellar Lesions) - Part A Week 16 n=41,14	5.30 ms Standard Error 9.17	3.61 ms Standard Error 15.46	—	—	—

PRIMARY outcome

Timeframe: Baseline up to Week 16, Week 28

Population: Pharmacodynamic (PD) analysis set: Subjects with available PD data

Collagen fibril organization in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality).The area of interest is the focal cartilage lesion.

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=17 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=9 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Change From Baseline in Articular Cartilage Collagen Organization in the Superficial Cartilage Layer (Femoral and Patellar Lesions) - Part A Week 16 n=17,7	-13.05 ms Standard Error 15.68	-13.93 ms Standard Error 24.73	—	—	—
Change From Baseline in Articular Cartilage Collagen Organization in the Superficial Cartilage Layer (Femoral and Patellar Lesions) - Part A Week 28 n=16,9	-10.45 ms Standard Error 16.61	-12.73 ms Standard Error 22.09	—	—	—

PRIMARY outcome

Timeframe: Baseline, Week 29, Week 53

Population: Pharmacodynamic (PD) analysis set: participants with baseline and at least one follow-up MRI assessments for volume of sufficient quality

MRI based quantitative assessment using an automated segmentation algorithm

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=12 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=13 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B n=13 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Change From Baseline of LNA043 to Placebo in Cartilage Volume in the Femoral Medial Index Region (mm3) - Part B Week 53 n=11,13,7	75.64 mm^3 Standard Error 54.48	-36.52 mm^3 Standard Error 51.21	-152.7 mm^3 Standard Error 67.72	—	—
Change From Baseline of LNA043 to Placebo in Cartilage Volume in the Femoral Medial Index Region (mm3) - Part B Week 29 n=12,13,13	45.52 mm^3 Standard Error 61.90	-12.79 mm^3 Standard Error 60.38	-154.7 mm^3 Standard Error 60.25	—	—

PRIMARY outcome

Timeframe: Baseline, Week 29, Week 53

Population: Pharmacodynamic (PD) analysis set: participants with baseline and at least one follow-up MRI assessments for thickness of sufficient quality

MRI based quantitative assessment using an automated segmentation algorithm.

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=12 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=13 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B n=13 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Change From Baseline of LNA043 to Placebo in Cartilage Thickness in the Femoral Medial Index Region (mm) - Part B Week 29 n=12,13,13	0.01 mm Standard Error 0.02	0.02 mm Standard Error 0.02	-0.04 mm Standard Error 0.02	—	—
Change From Baseline of LNA043 to Placebo in Cartilage Thickness in the Femoral Medial Index Region (mm) - Part B Week 53 n=11,13,7	-0.01 mm Standard Error 0.02	-0.00 mm Standard Error 0.02	-0.02 mm Standard Error 0.03	—	—

PRIMARY outcome

Timeframe: Baseline up to end of post treatment follow-up

Population: Safety analysis set

Treatment emergent other and serious adverse events (TEAE and TESAE) period: Part A: Baseline up to Day 50 (included 30 day safety follow-up Part B: Baseline up to Day 113 (included 30 day safety follow-up) Long term Follow-UP period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=43 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=15 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B n=27 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B n=27 Participants Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B n=29 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B Part A TESAE	0 participants	0 participants	—	—	—
Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B Part A - Follow-up AE	16 participants	1 participants	—	—	—
Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B Part A - Follow-up SAE	2 participants	0 participants	—	—	—
Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B Part B B - Follow-up SAE	—	—	1 participants	0 participants	2 participants
Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B Part A TEAE	19 participants	7 participants	—	—	—
Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B Part B - TEAE	—	—	6 participants	15 participants	10 participants
Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B Part B - TESAE	—	—	1 participants	0 participants	0 participants
Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B Part B - Follow-up AE	—	—	1 participants	1 participants	7 participants

SECONDARY outcome

Timeframe: Baseline up to Week 16, Week 28

Population: Pharmacodynamic (PD) analysis set: Subjects with available PD data

Cartilage volume data were generated from the manual segmentation of the cartilage defect that was identified in MR images.

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=40 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=15 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Change From Baseline of LNA043 to Placebo in Cartilage Defect Volume (mm^3) for Both Groups of Patients (Femoral and Patellar Lesions) - Part A Week 16 n=40,14	-2.42 mm^3 Standard Error 8.27	-7.17 mm^3 Standard Error 13.64	—	—	—
Change From Baseline of LNA043 to Placebo in Cartilage Defect Volume (mm^3) for Both Groups of Patients (Femoral and Patellar Lesions) - Part A Week 28 n=39,15	-11.88 mm^3 Standard Error 8.27	-4.57 mm^3 Standard Error 13.45	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 29, Week 53

Population: Pharmacodynamic (PD) analysis set: Subjects with available PD data

Collagen fibril organisation in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the femoral medial index region comprising the anterior, central and posterior aspects of the femoral condyle.

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=27 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=27 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B n=29 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Overall Part B Week 53 n=20,22,22	-4.23 ms Standard Error 2.29	-10.53 ms Standard Error 2.25	-3.09 ms Standard Error 2.18	—	—
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Overall Part B Week 29 n=21,21,25	-1.59 ms Standard Error 2.25	-5.07 ms Standard Error 2.26	-4.97 ms Standard Error 2.07	—	—

SECONDARY outcome

Timeframe: Baseline, Week 29, Week 53

Population: Pharmacodynamic (PD) analysis set: Subjects with available PD data

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=27 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=27 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B n=29 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Deep Part B Week 53 n=20,22,22	-3.93 ms Standard Error 2.53	-12.17 ms Standard Error 2.54	-6.21 ms Standard Error 2.41	—	—
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Deep Part B Week 29 n=21,21,25	-3.80 ms Standard Error 2.47	-5.07 ms Standard Error 2.49	-5.89 ms Standard Error 2.26	—	—

SECONDARY outcome

Timeframe: Baseline, Week 29, Week 53

Population: Pharmacodynamic (PD) analysis set: Subjects with available PD data

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=27 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=27 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B n=29 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Superficial Part B Week 29 n=21,21,25	-0.06 ms Standard Error 2.51	-4.16 ms Standard Error 2.51	-3.53 ms Standard Error 2.30	—	—
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Superficial Part B Week 53 n=20,22,22	-3.54 ms Standard Error 2.36	-9.07 ms Standard Error 2.36	-0.91 ms Standard Error 2.25	—	—

SECONDARY outcome

Timeframe: Week 1,3,8,16,28

Population: Safety analysis set

A validated ligand binding assay were used for the detection of anti-LNA043 antibodies, and cross-reactivity to ANGPTL3 and ANGPTL4.

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=43 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=15 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Incidence of Immunogenicity (IG) Part A Week 1 (Day 1) Predose	0 participants	0 participants	—	—	—
Incidence of Immunogenicity (IG) Part A Week 3 (Day 15) Pre-dose	0 participants	0 participants	—	—	—
Incidence of Immunogenicity (IG) Part A Week 8 (Day 50)	0 participants	0 participants	—	—	—
Incidence of Immunogenicity (IG) Part A Week 16 (Day 106)	0 participants	0 participants	—	—	—
Incidence of Immunogenicity (IG) Part A Week 28 (Day 190)	0 participants	0 participants	—	—	—

SECONDARY outcome

Timeframe: Week 1,5,9,13,17,29,53

Population: Safety analysis set

A validated ligand binding assay were used for the detection of anti-LNA043 antibodies, and cross-reactivity to ANGPTL3 and ANGPTL4.

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=27 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=27 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B n=29 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Incidence of Immunogenicity (IG) Part B Week 17	0 participants	0 participants	0 participants	—	—
Incidence of Immunogenicity (IG) Part B Week 29	0 participants	0 participants	0 participants	—	—
Incidence of Immunogenicity (IG) Part B Week 53	0 participants	0 participants	0 participants	—	—
Incidence of Immunogenicity (IG) Part B Week 1 (Day 1) Predose	0 participants	0 participants	0 participants	—	—
Incidence of Immunogenicity (IG) Part B Week 5 Pre-dose	0 participants	0 participants	0 participants	—	—
Incidence of Immunogenicity (IG) Part B Week 9	0 participants	0 participants	0 participants	—	—
Incidence of Immunogenicity (IG) Part B Week 13	0 participants	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: Week 1: 0 (pre-dose), 0.25 hours, 1, 2 hours post dose; Weeks 2, 3, 4: 0 hour (pre dose), 1 hour post dose

Population: Pharmacokinetic analysis set

Concentrations for LNA043 were determined by a validated LC-MS/MS method; the anticipated LLOQ was 10ng/mL in serum. Concentrations below the LLOQ were reported as "zero"

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=43 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Serum Concentrations of LNA043 - Part A Week 1, 0 hour pre-dose	0 ng/mL Standard Deviation 0	—	—	—	—
Serum Concentrations of LNA043 - Part A Week 1, 0.25 hour post dose n=6	24.9 ng/mL Standard Deviation 16.3	—	—	—	—
Serum Concentrations of LNA043 - Part A Week 2, 1 hour post dose n=43	48.1 ng/mL Standard Deviation 32.9	—	—	—	—
Serum Concentrations of LNA043 - Part A Week 3, 0 hour pre dose n=41	0.00 ng/mL Standard Deviation 0.00	—	—	—	—
Serum Concentrations of LNA043 - Part A Week 3, 1 hour post dose n=39	51.0 ng/mL Standard Deviation 37.6	—	—	—	—
Serum Concentrations of LNA043 - Part A Week 1, 1 hour post dose n=7	65.1 ng/mL Standard Deviation 30.2	—	—	—	—
Serum Concentrations of LNA043 - Part A Week 1, 2 hours post dose n=41	64.9 ng/mL Standard Deviation 37.5	—	—	—	—
Serum Concentrations of LNA043 - Part A Week 2,0 hour pre dose n=42	0.00 ng/mL Standard Deviation 0.00	—	—	—	—
Serum Concentrations of LNA043 - Part A Week 4, 0 hour pre dose n=42	3.00 ng/mL Standard Deviation 19.4	—	—	—	—
Serum Concentrations of LNA043 - Part A Week 4, 1 hour post dose n=41	52.9 ng/mL Standard Deviation 38.1	—	—	—	—

SECONDARY outcome

Timeframe: Week 1: 0 (pre-dose), 0.25 hours, 1, 2 hours post dose; Weeks 2, 3, 4: 0 hour (pre dose), 1 hour post dose

Population: Pharmacokinetic analysis set

Validated bioanalytical assays were used to determine ANGPTL3 in serum with an LLOQ of 2.13 ng/mL. Concentrations below the LLOQ were reported as "zero"

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=43 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=15 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Serum Concentrations of ANGPTL3 - Part A Week 1, 0 hour pre-dose n=41,14	19.1 ng/mL Standard Deviation 9.29	23.3 ng/mL Standard Deviation 8.55	—	—	—
Serum Concentrations of ANGPTL3 - Part A Week 1, 0.25 hour post dose n=6,2	20.8 ng/mL Standard Deviation 8.12	20.4 ng/mL Standard Deviation 6.36	—	—	—
Serum Concentrations of ANGPTL3 - Part A Week 2, 1 hour post dose n=42,15	18.3 ng/mL Standard Deviation 8.06	19.7 ng/mL Standard Deviation 9.58	—	—	—
Serum Concentrations of ANGPTL3 - Part A Week 3, 0 hour pre dose n=42,14	19.1 ng/mL Standard Deviation 7.79	24.2 ng/mL Standard Deviation 9.95	—	—	—
Serum Concentrations of ANGPTL3 - Part A Week 3, 1 hour post dose n=39,14	18.5 ng/mL Standard Deviation 7.35	28.9 ng/mL Standard Deviation 16.4	—	—	—
Serum Concentrations of ANGPTL3 - Part A Week 4, 0 hour pre dose n=42,15	19.6 ng/mL Standard Deviation 8.71	21.0 ng/mL Standard Deviation 7.11	—	—	—
Serum Concentrations of ANGPTL3 - Part A Week 4, 1 hour post dose n=41,15	19.6 ng/mL Standard Deviation 7.87	22.6 ng/mL Standard Deviation 9.06	—	—	—
Serum Concentrations of ANGPTL3 - Part A Week 1, 1 hour post dose n=7,2	19.7 ng/mL Standard Deviation 8.65	18.2 ng/mL Standard Deviation 3.32	—	—	—
Serum Concentrations of ANGPTL3 - Part A Week 1, 2 hours post dose n=40,15	18.9 ng/mL Standard Deviation 9.38	24.3 ng/mL Standard Deviation 9.52	—	—	—
Serum Concentrations of ANGPTL3 - Part A Week 2,0 hour pre dose n=42,15	18.9 ng/mL Standard Deviation 10.3	21.7 ng/mL Standard Deviation 10.2	—	—	—

SECONDARY outcome

Timeframe: Weeks 1,2,3,4: 0 hour (pre-dose)

Population: LNA043 Stability in synovial fluid could not be demonstrated. Consequently, the assay was not considered suitable for the determination of LNA043 in synovial fluid collected in Part A and no reportable concentrations of LNA043 in synovial fluid are available in Part A, samples were never assayed and so data are not available for LNA043 concentrations in synovial fluid for Part A.

Concentrations for LNA043 were determined by a validated LC-MS/MS method; the anticipated LLOQ was 10ng/mL in synovial fluid. Concentrations below the LLOQ were reported as "zero".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 1,2,3,4: 0 hour (pre-dose)

Population: Pharmacokinetic analysis set

Validated bioanalytical assays were used to determine ANGPTL3 in synovial fluid with an LLOQ of 2.74 ng/mL. Concentrations below the LLOQ were reported as "zero".

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=43 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=15 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Synovial Fluid Concentrations of ANGPTL3 - Part A Week 1, 0 hour pre-dose n=8,3	0.00 ng/mL Standard Deviation 0.00	00.0 ng/mL Standard Deviation 00.0	—	—	—
Synovial Fluid Concentrations of ANGPTL3 - Part A Week 2,0 hour pre dose n=11,5	0.00 ng/mL Standard Deviation 0.00	00.0 ng/mL Standard Deviation 00.0	—	—	—
Synovial Fluid Concentrations of ANGPTL3 - Part A Week 3, 0 hour pre dose n=13,4	0.616 ng/mL Standard Deviation 2.22	00.0 ng/mL Standard Deviation 00.0	—	—	—
Synovial Fluid Concentrations of ANGPTL3 - Part A Week 4, 0 hour pre dose n=15,3	1.42 ng/mL Standard Deviation 5.50	00.0 ng/mL Standard Deviation 00.0	—	—	—

SECONDARY outcome

Timeframe: Week 1: 0 (pre-dose), 2 hours post dose; Weeks 5 and 13: 1 hour post dose

Population: Pharmacokinetic analysis set

Concentrations for LNA043 were determined by a validated LC-MS/MS method; the anticipated LLOQ was 10ng/mL in serum. Concentrations below the LLOQ were reported as "zero

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=27 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=27 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Serum Concentrations of LNA043 - Part B Week 13, 1 hour post dose n=27,25	59.5 ng/mL Standard Deviation 53.0	118 ng/mL Standard Deviation 78.2	—	—	—
Serum Concentrations of LNA043 - Part B Week 1, 0 hours pre-dose n=27,26	3.48 ng/mL Standard Deviation 18.1	7.96 ng/mL Standard Deviation 40.6	—	—	—
Serum Concentrations of LNA043 - Part B Week 1, 2 hours post dose n=24,24,	76.4 ng/mL Standard Deviation 51.0	158 ng/mL Standard Deviation 94.0	—	—	—
Serum Concentrations of LNA043 - Part B Week 5, 1 hour post dose n=27,26	55.6 ng/mL Standard Deviation 47.0	101 ng/mL Standard Deviation 74.2	—	—	—

SECONDARY outcome

Timeframe: Week 1: 0 (pre-dose), 2 hours post dose; Weeks 5 and 13: 1 hour post dose

Population: Pharmacokinetic analysis set

Validated bioanalytical assays were used to determine ANGPTL3 in serum with an LLOQ of 2.13 ng/mL. Concentrations below the LLOQ were reported as "zero".

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=27 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=26 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B n=29 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Serum Concentrations of ANGPTL3 - Part B Week 1, 0 hour pre-dose n=27,26,29	25.3 ng/mL Standard Deviation 11.1	21.9 ng/mL Standard Deviation 9.09	26.6 ng/mL Standard Deviation 14.0	—	—
Serum Concentrations of ANGPTL3 - Part B Week 1, 2 hours post dose n=24,24,26	26.0 ng/mL Standard Deviation 12.8	23.9 ng/mL Standard Deviation 10.6	27.6 ng/mL Standard Deviation 13.1	—	—
Serum Concentrations of ANGPTL3 - Part B Week 5, 1 hour post dose n=26,26,28	21.8 ng/mL Standard Deviation 9.80	23.3 ng/mL Standard Deviation 9.97	26.2 ng/mL Standard Deviation 10.8	—	—
Serum Concentrations of ANGPTL3 - Part B Week 13, 1 hour post dose n=27,25,28	22.9 ng/mL Standard Deviation 8.72	22.5 ng/mL Standard Deviation 8.39	24.8 ng/mL Standard Deviation 11.8	—	—

SECONDARY outcome

Timeframe: Weeks 1,5.9.13: 0 hour (pre-dose)

Population: Pharmacokinetic analysis set

Concentrations for LNA043 were determined by a validated LC-MS/MS method; the anticipated LLOQ was 10ng/mL in synovial fluid. Concentrations below the LLOQ were reported as "zero".

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=11 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=6 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Synovial Fluid Concentrations of LNA043 Part B Week 13, 0 hours pre dose n=8,4	0.00 ng/mL Standard Deviation 0.00	199000 ng/mL Standard Deviation 398000	—	—	—
Synovial Fluid Concentrations of LNA043 Part B Week 1, 0 hours pre dose n=9,5	28.9 ng/mL Standard Deviation 86.7	0.00 ng/mL Standard Deviation 0.00	—	—	—
Synovial Fluid Concentrations of LNA043 Part B Week 5, 0 hours pre dose n=10,5	368 ng/mL Standard Deviation 1160	18.1 ng/mL Standard Deviation 40.6	—	—	—
Synovial Fluid Concentrations of LNA043 Part B Week 9, 0 hours pre-dose n=11,6	0.00 ng/mL Standard Deviation 0.00	43600 ng/mL Standard Deviation 90900	—	—	—

SECONDARY outcome

Timeframe: Weeks 1,5.9.13: 0 hour (pre-dose)

Population: Pharmacokinetic analysis set

Validated bioanalytical assays were used to determine ANGPTL3 in synovial fluid with an LLOQ of 2.74 ng/mL. Concentrations below the LLOQ were reported as "zero".

Outcome measures

Outcome measures
Measure	LNA043 20 mg Part A n=10 Participants Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee.	Placebo Part A n=5 Participants Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee	Placebo Part B n=12 Participants Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis	LNA043 40mg Part B Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.	Placebo Part B Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis.
Synovial Fluid Concentrations of ANGPTL3 - Part B Week 1, 0 hour pre-dose n=8,3,8	0.00 ng/mL Standard Deviation 0.00	0.00 ng/mL Standard Deviation 0.00	0.00 ng/mL Standard Deviation 0.00	—	—
Synovial Fluid Concentrations of ANGPTL3 - Part B 0.00Week 5,,0 hour pre dose n=10,5,12	1.00 ng/mL Standard Deviation 3.16	4.38 ng/mL Standard Deviation 9.79	1.57 ng/mL Standard Deviation 5.43	—	—
Synovial Fluid Concentrations of ANGPTL3 - Part B Week 9,, 0 hour pre dose n=8,4,9	0.00 ng/mL Standard Deviation 0.00	0.00 ng/mL Standard Deviation 0.00	0.00 ng/mL Standard Deviation 0.00	—	—
Synovial Fluid Concentrations of ANGPTL3 - Part B Week 13, 0 hour pre dose n=7,4,8	0.00 ng/mL Standard Deviation 0.00	1.87 ng/mL Standard Deviation 3.74	0.890 ng/mL Standard Deviation 2.52	—	—

Adverse Events

LNA043 20 mg Part A - TE

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo Part A - TE

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

LNA043 20 mg Part B - TE

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

LNA043 40 mg Part B - TE

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo Part B - TE

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

LNA043 20 mg Part A - FU

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo Part A - FU

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

LNA043 20 mg Part B - FU

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

LNA043 40 mg Part B - FU

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo Part B - FU

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LNA043 20 mg Part A - TE n=43 participants at risk Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee. Treatment Emergent (TE) AEs are reported Baseline up to Day 50.	Placebo Part A - TE n=15 participants at risk Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee. Treatment Emergent (TE) AEs are reported Baseline up to Day 50.	LNA043 20 mg Part B - TE n=27 participants at risk Part B: a single intra-articular injection of 20 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. Treatment Emergent (TE) AEs are reported Baseline up to Day 113.	LNA043 40 mg Part B - TE n=27 participants at risk Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. Treatment Emergent (TE) AEs are reported Baseline up to Day 113.	Placebo Part B - TE n=29 participants at risk Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. Treatment Emergent (TE) AEs are reported Baseline up to Day 113.	LNA043 20 mg Part A - FU n=43 participants at risk Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee. AEs in long term Follow-Up (FU) period are reported form Day 51 to Day 365.	Placebo Part A - FU n=15 participants at risk Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee. AEs in long term Follow-Up (FU) period are reported form Day 51 to Day 365.	LNA043 20 mg Part B - FU n=27 participants at risk Part B: a single intra-articular injection of 20 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. AEs in long term Follow-Up (FU) period are reported form Day 114 to Day 365.	LNA043 40 mg Part B - FU n=27 participants at risk Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. AEs in long term Follow-Up (FU) period are reported form Day 114 to Day 365.	Placebo Part B - FU n=29 participants at risk Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. AEs in long term Follow-Up (FU) period are reported form Day 114 to Day 365.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Congenital, familial and genetic disorders Odontogenic cyst	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Colitis ischaemic	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations COVID-19 pneumonia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Vascular disorders Deep vein thrombosis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Vascular disorders Vena cava thrombosis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365

Other adverse events

Other adverse events
Measure	LNA043 20 mg Part A - TE n=43 participants at risk Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee. Treatment Emergent (TE) AEs are reported Baseline up to Day 50.	Placebo Part A - TE n=15 participants at risk Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee. Treatment Emergent (TE) AEs are reported Baseline up to Day 50.	LNA043 20 mg Part B - TE n=27 participants at risk Part B: a single intra-articular injection of 20 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. Treatment Emergent (TE) AEs are reported Baseline up to Day 113.	LNA043 40 mg Part B - TE n=27 participants at risk Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. Treatment Emergent (TE) AEs are reported Baseline up to Day 113.	Placebo Part B - TE n=29 participants at risk Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. Treatment Emergent (TE) AEs are reported Baseline up to Day 113.	LNA043 20 mg Part A - FU n=43 participants at risk Part A: a single intra-articular injection of 20 mg LNA043 was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee. AEs in long term Follow-Up (FU) period are reported form Day 51 to Day 365.	Placebo Part A - FU n=15 participants at risk Part A: a single intra-articular injection of matching placebo (0 mg) was administered weekly for 4 weeks for participants with focal cartilage lesions of the knee. AEs in long term Follow-Up (FU) period are reported form Day 51 to Day 365.	LNA043 20 mg Part B - FU n=27 participants at risk Part B: a single intra-articular injection of 20 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. AEs in long term Follow-Up (FU) period are reported form Day 114 to Day 365.	LNA043 40 mg Part B - FU n=27 participants at risk Part B: a single intra-articular injection of 40 mg LNA043 was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. AEs in long term Follow-Up (FU) period are reported form Day 114 to Day 365.	Placebo Part B - FU n=29 participants at risk Part B: a single intra-articular injection of matching placebo (0 mg) was administered every 4 weeks from Week 1 to Week 13 (4 injections) for participants with osteoarthritis. AEs in long term Follow-Up (FU) period are reported form Day 114 to Day 365.
Musculoskeletal and connective tissue disorders Back pain	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	4.7% 2/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Joint swelling	9.3% 4/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	10.3% 3/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Myalgia	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	4.7% 2/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Blood and lymphatic system disorders Anaemia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Blood and lymphatic system disorders Anaemia macrocytic	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Blood and lymphatic system disorders Leukocytosis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Cardiac disorders Atrial fibrillation	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Cardiac disorders Coronary artery disease	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Congenital, familial and genetic disorders Homocystinaemia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Congenital, familial and genetic disorders Odontogenic cyst	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Endocrine disorders Thyroid mass	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Eye disorders Cataract	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Abdominal distension	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Abdominal pain	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.9% 2/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Abdominal pain upper	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Dental caries	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Diarrhoea	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Faecaloma	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Haematochezia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Haemorrhoids	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.9% 2/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Hiatus hernia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Large intestine polyp	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Oesophagitis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Gastrointestinal disorders Toothache	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
General disorders Inflammation	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
General disorders Injection site bruising	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
General disorders Injection site erythema	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
General disorders Injection site haematoma	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
General disorders Injection site joint erythema	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
General disorders Injection site joint pain	4.7% 2/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
General disorders Peripheral swelling	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
General disorders Pyrexia	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
General disorders Vessel puncture site haemorrhage	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations Bronchitis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations COVID-19	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.9% 2/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations COVID-19 pneumonia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations Gastroenteritis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations Gingivitis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations Herpes zoster	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations Infected dermal cyst	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations Nasopharyngitis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations Respiratory tract infection viral	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations Tonsillitis	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations Upper respiratory tract infection	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	4.7% 2/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Infections and infestations Urinary tract infection	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Bone contusion	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Fall	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Limb injury	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Meniscus cyst	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Muscle strain	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	4.7% 2/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Nail injury	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Procedural pain	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Tendon injury	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Investigations Alanine aminotransferase increased	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Investigations Blood creatine phosphokinase increased	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.9% 2/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Investigations Blood pressure increased	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Investigations Blood uric acid increased	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	7.4% 2/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Investigations Cardiac murmur	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Investigations Gamma-glutamyltransferase increased	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Investigations Haematology test abnormal	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Investigations Hepatic enzyme increased	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Investigations SARS-CoV-2 test positive	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Investigations Urine protein/creatinine ratio increased	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Arthralgia	7.0% 3/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	14.8% 4/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	7.0% 3/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	7.4% 2/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.9% 2/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Musculoskeletal and connective tissue disorders Pain in extremity	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Nervous system disorders Dizziness	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Nervous system disorders Headache	14.0% 6/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Nervous system disorders Paraesthesia	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Nervous system disorders Seizure	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Nervous system disorders Syncope	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Psychiatric disorders Depression	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Psychiatric disorders Sleep disorder	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Renal and urinary disorders Microalbuminuria	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Reproductive system and breast disorders Atrophic vulvovaginitis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Reproductive system and breast disorders Breast pain	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Reproductive system and breast disorders Ovulation pain	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	6.7% 1/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Skin and subcutaneous tissue disorders Eczema	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Skin and subcutaneous tissue disorders Lichenoid keratosis	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Skin and subcutaneous tissue disorders Rash	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.4% 1/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Vascular disorders Haematoma	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	3.7% 1/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Vascular disorders Varicose vein	0.00% 0/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	2.3% 1/43 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/15 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/27 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365	0.00% 0/29 • Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER