Trial Outcomes & Findings for A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses (NCT NCT04118127)

Participant milestones
Measure	Cohort 2 Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Period 2(Cohort 2). Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects repeated administration of the QW formulation at 48 mg on Days 8, 15, 22, and 29.	Cohort 1 Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 1 Period 2. Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects washed out brexpiprazole for 27 days until Cohort 1 Period 3. Subjects received a brexpiprazole QW formulation at 48 mg on Day 1
Overall Study STARTED	35	38
Overall Study COMPLETED	32	22
Overall Study NOT COMPLETED	3	16

Reasons for withdrawal
Measure	Cohort 2 Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Period 2(Cohort 2). Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects repeated administration of the QW formulation at 48 mg on Days 8, 15, 22, and 29.	Cohort 1 Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 1 Period 2. Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects washed out brexpiprazole for 27 days until Cohort 1 Period 3. Subjects received a brexpiprazole QW formulation at 48 mg on Day 1
Overall Study Trial terminated by sponsor	0	12
Overall Study Adverse Event	1	2
Overall Study Physician Decision	0	1
Overall Study Withdrawal by Subject	2	1

Baseline characteristics by cohort
Measure	Cohort 1 Period 1 n=38 Participants Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 1 Period 2.	Cohort 2 Period 1 n=35 Participants Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Period 2(Cohort 2).	Total n=73 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 9.7 • n=39 Participants	47.1 years STANDARD_DEVIATION 10.6 • n=41 Participants	46.9 years STANDARD_DEVIATION 10.1 • n=35 Participants
Sex: Female, Male Female	14 Participants n=39 Participants	16 Participants n=41 Participants	30 Participants n=35 Participants
Sex: Female, Male Male	24 Participants n=39 Participants	19 Participants n=41 Participants	43 Participants n=35 Participants
Race/Ethnicity, Customized Asian	38 Participants n=39 Participants	35 Participants n=41 Participants	73 Participants n=35 Participants
Region of Enrollment Japan	38 Participants n=39 Participants	35 Participants n=41 Participants	73 Participants n=35 Participants

Outcome measures
Measure	Conventional Tablet 2mg n=33 Participants Subjects received a brexpiprazole 2 mg conventional tablet on Day 1.	QW Formuration 24mg n=33 Participants Subjects received a brexpiprazole QW formulation at 24 mg on Day 1.	QW Formuration 48mg n=22 Participants Subjects received a brexpiprazole QW formulation at 48 mg on Day 1
Maximum Plasma Concentration (Cmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1	25.37 ng/mL Standard Deviation 10.46	98.62 ng/mL Standard Deviation 46.76	222.3 ng/mL Standard Deviation 114.3

Outcome measures
Measure	Conventional Tablet 2mg n=33 Participants Subjects received a brexpiprazole 2 mg conventional tablet on Day 1.	QW Formuration 24mg n=33 Participants Subjects received a brexpiprazole QW formulation at 24 mg on Day 1.	QW Formuration 48mg n=22 Participants Subjects received a brexpiprazole QW formulation at 48 mg on Day 1
Time to Maximum (Peak) Plasma Concentration (Tmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1	4.00 hour Interval 1.75 to 24.37	25.37 hour Interval 8.75 to 49.5	25.00 hour Interval 8.6 to 46.42

Outcome measures
Measure	Conventional Tablet 2mg n=32 Participants Subjects received a brexpiprazole 2 mg conventional tablet on Day 1.	QW Formuration 24mg Subjects received a brexpiprazole QW formulation at 24 mg on Day 1.	QW Formuration 48mg Subjects received a brexpiprazole QW formulation at 48 mg on Day 1
Cmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2	225.0 ng/mL Standard Deviation 147.7	—	—

Outcome measures
Measure	Conventional Tablet 2mg n=32 Participants Subjects received a brexpiprazole 2 mg conventional tablet on Day 1.	QW Formuration 24mg Subjects received a brexpiprazole QW formulation at 24 mg on Day 1.	QW Formuration 48mg Subjects received a brexpiprazole QW formulation at 48 mg on Day 1
Tmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2	24.61 hour Interval 8.5 to 49.25	—	—

Serious adverse events
Measure	Cohort 1 Period 2 n=34 participants at risk Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects washed out brexpiprazole for 27 days until Period 3(Cohort 1).	Cohort 1 Period 3 n=23 participants at risk Subjects received a brexpiprazole QW formulation at 48 mg on Day 1	Cohort 2 Period 2 n=34 participants at risk Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects repeated administration of the QW formulation at 48 mg on Days 8, 15, 22, and 29.	Cohort 1 Period 1 n=38 participants at risk Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 1 Period 2.	Cohort 2 Period 1 n=35 participants at risk Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 2 Period 2.
Psychiatric disorders Schizophrenia	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Other adverse events
Measure	Cohort 1 Period 2 n=34 participants at risk Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects washed out brexpiprazole for 27 days until Period 3(Cohort 1).	Cohort 1 Period 3 n=23 participants at risk Subjects received a brexpiprazole QW formulation at 48 mg on Day 1	Cohort 2 Period 2 n=34 participants at risk Subjects received a brexpiprazole QW formulation at 24 mg on Day 1. Subjects repeated administration of the QW formulation at 48 mg on Days 8, 15, 22, and 29.	Cohort 1 Period 1 n=38 participants at risk Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 1 Period 2.	Cohort 2 Period 1 n=35 participants at risk Subjects received a brexpiprazole 2 mg conventional tablet on Day 1. Subjects washed out brexpiprazole for 20 days until Cohort 2 Period 2.
Blood and lymphatic system disorders Iron Deficiency Anaemia	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Cardiac disorders Atrioventricular Block First Degree	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Cardiac disorders Bradycardia	5.9% 2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Cardiac disorders Tachycardia	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Endocrine disorders Hyperprolactinaemia	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Eye disorders Dry Eye	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Abdominal Pain	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Abdominal Pain Upper	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Dental Caries	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Diarrhoea	8.8% 3/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	8.6% 3/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Nausea	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Toothache	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.7% 2/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Vomiting	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	8.7% 2/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
General disorders Malaise	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
General disorders Pyrexia	5.9% 2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
General disorders Thirst	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Conjunctivitis	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Folliculitis	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Infected Dermal Cyst	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Nasopharyngitis	8.8% 3/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.9% 2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.3% 2/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.7% 2/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Oral Herpes	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Skin Infection	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Injury, poisoning and procedural complications Contusion	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Alanine Aminotransferase Increased	8.8% 3/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Aspartate Aminotransferase Increased	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Bilirubin Increased	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.9% 2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Glucose Decreased	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Insulin Increased	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.7% 2/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Lactate Dehydrogenase Increased	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Pressure Decreased	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Pressure Increased	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Pressure Systolic Decreased	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Pressure Systolic Increased	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Prolactin Increased	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Platelet Count Decreased	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Urinary Occult Blood Positive	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Weight Decreased	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Weight Increased	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations White Blood Cell Count Decreased	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Metabolism and nutrition disorders Hypertriglyceridaemia	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Musculoskeletal and connective tissue disorders Arthralgia	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.7% 2/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Musculoskeletal and connective tissue disorders Back Pain	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Musculoskeletal and connective tissue disorders Muscle Rigidity	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Musculoskeletal and connective tissue disorders Muscle Spasms	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Akathisia	5.9% 2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	13.0% 3/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Dizziness	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.9% 2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Dizziness Postural	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Dyskinesia	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Dystonia	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Extrapyramidal Disorder	5.9% 2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Headache	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	11.8% 4/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	7.9% 3/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Hypoaesthesia	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Loss of Consciousness	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Mental Impairment	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Restless Legs Syndrome	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Sedation	5.9% 2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Somnolence	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	11.8% 4/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.3% 2/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Taste Disorder	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Psychiatric disorders Hallucination	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Psychiatric disorders Insomnia	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.9% 2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Renal and urinary disorders Hallucination	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Renal and urinary disorders Urinary Incontinence	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Reproductive system and breast disorders Menstrual Disorder	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Respiratory, thoracic and mediastinal disorders Epistaxis	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	4.3% 1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Skin and subcutaneous tissue disorders Eczema	5.9% 2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Skin and subcutaneous tissue disorders Erythema	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Skin and subcutaneous tissue disorders Pruritus	2.9% 1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Eye disorders Ocular Hyperaemia	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	5.7% 2/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Faeces Hard	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Haemorrhoids	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Gastrointestinal disorders Salivary Hypersecretion	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
General disorders Injection Site Pruritu	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Gingivitis	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Influenza	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Pharyngitis	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Pneumonia	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Pyoderma	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Injury, poisoning and procedural complications Tooth Fracture	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Cholesterol Increased	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Triglycerides Increased	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Investigations Blood Uric Acid Increased	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Nervous system disorders Vagus Nerve Disorder	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Psychiatric disorders Schizophrenia	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Reproductive system and breast disorders Scrotal Dermatitis	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Skin and subcutaneous tissue disorders Haemorrhage Subcutaneous	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Skin and subcutaneous tissue disorders Rash	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Vascular disorders Hypotension	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.6% 1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).
Skin and subcutaneous tissue disorders Dermatitis Atopic	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	0.00% 0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).	2.9% 1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days) Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Blood and lymphatic system disorders

Iron Deficiency Anaemia

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Cardiac disorders

Atrioventricular Block First Degree

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Cardiac disorders

Bradycardia

5.9%

2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Cardiac disorders

Tachycardia

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Endocrine disorders

Hyperprolactinaemia

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Eye disorders

Dry Eye

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Abdominal Pain

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Abdominal Pain Upper

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Dental Caries

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Diarrhoea

8.8%

3/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

8.6%

3/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Nausea

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Toothache

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.7%

2/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Vomiting

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

8.7%

2/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

General disorders

Malaise

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

General disorders

Pyrexia

5.9%

2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

General disorders

Thirst

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Conjunctivitis

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Folliculitis

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Infected Dermal Cyst

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Nasopharyngitis

8.8%

3/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.9%

2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.3%

2/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.7%

2/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Oral Herpes

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Skin Infection

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Injury, poisoning and procedural complications

Contusion

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Injury, poisoning and procedural complications

Ligament Sprain

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Injury, poisoning and procedural complications

Skin Abrasion

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Alanine Aminotransferase Increased

8.8%

3/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Aspartate Aminotransferase Increased

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Bilirubin Increased

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Creatine Phosphokinase Increased

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.9%

2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Glucose Decreased

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Insulin Increased

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.7%

2/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Lactate Dehydrogenase Increased

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Pressure Decreased

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Pressure Increased

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Pressure Systolic Decreased

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Pressure Systolic Increased

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Prolactin Increased

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Platelet Count Decreased

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Urinary Occult Blood Positive

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Weight Decreased

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Weight Increased

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

White Blood Cell Count Decreased

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Metabolism and nutrition disorders

Decreased Appetite

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Metabolism and nutrition disorders

Hypertriglyceridaemia

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Musculoskeletal and connective tissue disorders

Arthralgia

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.7%

2/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Musculoskeletal and connective tissue disorders

Back Pain

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Musculoskeletal and connective tissue disorders

Muscle Rigidity

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Musculoskeletal and connective tissue disorders

Muscle Spasms

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Akathisia

5.9%

2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

13.0%

3/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Dizziness

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.9%

2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Dizziness Postural

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Dyskinesia

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Dystonia

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Extrapyramidal Disorder

5.9%

2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Headache

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

11.8%

4/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

7.9%

3/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Hypoaesthesia

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Loss of Consciousness

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Mental Impairment

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Restless Legs Syndrome

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Sedation

5.9%

2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Somnolence

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

11.8%

4/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.3%

2/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Taste Disorder

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Psychiatric disorders

Hallucination

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Psychiatric disorders

Insomnia

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.9%

2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Renal and urinary disorders

Hallucination

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Renal and urinary disorders

Urinary Incontinence

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Reproductive system and breast disorders

Menstrual Disorder

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Respiratory, thoracic and mediastinal disorders

Epistaxis

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Skin and subcutaneous tissue disorders

Dermatitis

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Skin and subcutaneous tissue disorders

Dermatitis Contact

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

4.3%

1/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Skin and subcutaneous tissue disorders

Eczema

5.9%

2/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Skin and subcutaneous tissue disorders

Erythema

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Skin and subcutaneous tissue disorders

Pruritus

2.9%

1/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Eye disorders

Ocular Hyperaemia

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Abdominal Discomfort

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

5.7%

2/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Faeces Hard

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Haemorrhoidal Haemorrhage

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Haemorrhoids

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Gastrointestinal disorders

Salivary Hypersecretion

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

General disorders

Injection Site Pruritu

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Gingivitis

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Influenza

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Pharyngitis

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Pneumonia

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Pyoderma

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Infections and infestations

Upper Respiratory Tract Infection

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Injury, poisoning and procedural complications

Tooth Fracture

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Cholesterol Increased

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Triglycerides Increased

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Investigations

Blood Uric Acid Increased

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Musculoskeletal and connective tissue disorders

Musculoskeletal Stiffness

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Musculoskeletal and connective tissue disorders

Pain in Extremity

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Nervous system disorders

Vagus Nerve Disorder

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Psychiatric disorders

Schizophrenia

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Reproductive system and breast disorders

Scrotal Dermatitis

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Respiratory, thoracic and mediastinal disorders

Oropharyngeal Pain

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Skin and subcutaneous tissue disorders

Haemorrhage Subcutaneous

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Skin and subcutaneous tissue disorders

Rash

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Vascular disorders

Hypotension

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.6%

1/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Skin and subcutaneous tissue disorders

Dermatitis Atopic

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/23 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/34 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

0.00%

0/38 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

2.9%

1/35 • From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days)

Adverse events (AEs) in each participant were monitored in each period of Cohort 1 and 2, with the maximum duration as indicated above, from after the IMP administration in each period until before the IMP administration in the next period (for Cohort 1 period 1-2 and Cohort 2 period 1) or the end of study (for Cohort 1 period 3 and Cohort 2 period 2). AEs were assessed separately in Cohort 1 (period 1-3) and Cohort 2 (period 1-2).

Trial Outcomes & Findings for A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses (NCT NCT04118127)

Results Overview

Participant Flow

Participant milestones

Reasons for withdrawal

Baseline Characteristics

Baseline characteristics by cohort

PRIMARY outcome

Outcome measures

PRIMARY outcome

Outcome measures

PRIMARY outcome

Outcome measures

PRIMARY outcome

Outcome measures

Adverse Events

Cohort 1 Period 2

Cohort 1 Period 3

Cohort 2 Period 2

Cohort 1 Period 1

Cohort 2 Period 1

Serious adverse events

Other adverse events

Additional Information

Director of Clinical Trials

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